Disinfecting methods and apparatus

ABSTRACT

According to one implementation an assembly is provided that includes an optical fiber having a length and an infusion shaft having a lumen in which at least a first portion of the length of the optical fiber resides. A hub that is connected to the infusion shaft has a channel that houses at least a second portion of the length of the optical fiber. T second portion of the length of the optical fiber is not held taut along at least a portion of the length of the channel.

TECHNICAL FIELD

The present disclosure relates to devices having disinfectingcapabilities and to methods for disinfecting any of a host of devicesincluding, for example, devices used in the medical treatment ofpatients.

BACKGROUND

Unwanted and dangerous bacteria growth can occur on or in devices thatare commonly used to treat patients. These devices may include centralvenous catheters, urinary catheters, ventilators, wound protectiondevices, etc. Hospital acquired infections account for a substantialyearly expense to hospitals and insurance companies, and are a majorcause of extending hospital stays for patients. Equipment or componentsof water processing plants, food processing plants, dairies, livestockhabitation facilities, etc. are also susceptible bacteria growth.

SUMMARY OF THE DISCLOSURE

According to some implementations disclosed herein light is used todisinfect the internal and/or external surfaces of devices used in themedical treatment of patients. The light may be any wavelength of lightthat is capable of killing bacteria, such as, for example, ultra violet(UV) light and blue light which may be delivered by one or both of aradially emitting optical fiber and an end emitting optical fiber.

An advantage of using light to kill bacteria is that it is notsusceptible to the danger of antimicrobial resistance that can occurwith the use of pharmacologic or chemical agents. Another advantage isthat there are severe side effects associated with many pharmacologic orchemical agents are avoided.

According to other implementations light based detection means is usedto monitor the formation of clots and/or bacterial biofilms on the outersurface of catheters residing in a vessel or duct of a patient.

It is important to note that although the forthcoming disclosure isdirected primarily to medical devices, it is in no way limited to suchdevices. For example, the apparatus and methods disclosed herein relatedto killing bacteria with light and the monitoring of clot or biofilmgrowth can also be applied to equipment or components of waterprocessing plants, food processing plants, dairies, livestock habitationfacilities, etc.

These and other advantages and features will become evident in view ofthe drawings and detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B respectively show a side view and cross-section view ofa radially emitting optical fiber according to some implementation;

FIG. 2 is a perspective view of an end emitting optical fiber accordingto some implementations;

FIG. 3 is a perspective view of a central venous catheter assemblyaccording to some implementations.

FIG. 4A is a cross-section view of a main shaft of a central venouscatheter according to one implementation.

FIG. 4B is a perspective view of the main shaft depicted in FIG. 4A.

FIG. 4C is a perspective view of a distal end portion of the main shaftdepicted in FIGS. 4A and 4B.

FIG. 4D is a perspective view of a proximal end portion of the mainshaft according to one implementation.

FIGS. 5A and 5B show cross-section views of a main shaft of a centralvenous catheter according to other implementations.

FIG. 6 shows a distal end portion of the main shaft having a spiralimaging fiber located adjacent apertures in the main shaft that extendto an exterior surface of the main shaft.

FIGS. 7A and 7B illustrate an imaging system associated with a mainshaft of a central venous catheter according to one implementation.

FIG. 8A is an external perspective view of an infusion shaft accordingto one implementation.

FIG. 8B is an exploded view of the infusion shaft of FIG. 8A.

FIGS. 9A and 9B are cross-section views of a tubular body of an infusionshaft according to one implementation.

FIGS. 9C through 9F show alternative exemplary implementations of aninfusion shaft having reflectors that guide the light emitted by theradially emitting fiber into the working lumen.

FIGS. 10A-C illustrate cross-section views of the main shaft accordingto other implementations.

FIG. 11A illustrates an implementation of a clamp used to close off flowthrough an infusion shaft with the clamp being in the open position.

FIG. 11B illustrates the clamp of FIG. 11A being in the closed position.

FIG. 11C illustrates the infusion shaft running through the clamp ofFIG. 11A with the clamp being in the open position.

FIG. 12 is a cross-section side view of a tubular body of an infusionshaft according to one implementation.

FIG. 13 is a perspective view of the proximal end portion of the tubularbody of FIG.

FIG. 14A is a cross-section side view of an infusion shaft proximalconnector according to one implementation.

FIG. 14B is a cross-section view showing the proximal end segment of thekey portion of the tubular body inserted into the receiving lumen of theproximal connector.

FIG. 15 illustrates a path of the light emitted by the end emittingfiber through the proximal connector of FIG. 13.

FIG. 16 is an external perspective view of an infusion shaft proximalconnector according to one implementation.

FIG. 17 is an internal view of the guidewire ramp and optical surface ofFIG. 13.

FIG. 18 is a perspective view of the cap of FIG. 13.

FIGS. 19A-D illustrate cross-section side views of a portions of aninfusion shaft according to other implementations.

FIG. 20A is a cross-section side view of an infusion shaft proximalconnector according to one implementation.

FIG. 20B illustrates a path of the light emitted by the end emittingfiber through the proximal connector of FIG. 20A.

FIG. 21A is a cross-section side view of an infusion shaft proximalconnector according to one implementation.

FIG. 21B illustrates a path of the light emitted by the end emittingfiber through the proximal connector of FIG. 21A.

FIG. 22A illustrates a laser system that delivers light from a singlelaser to eight optical fibers of a central venous catheter according toone implementation.

FIG. 22B illustrates a laser system that delivers light from eightlasers to a respective eight optical fibers of a central venous catheteraccording to one implementation.

FIG. 22C illustrates a laser system that delivers light from threelasers to eight optical fibers of a central venous catheter according toone implementation.

FIG. 23 shows a top view of an optical umbilical cord of a centralvenous catheter according to one implementation.

FIG. 24A shows a perspective view of a distal end of the umbilical cordof FIG. 23 according to one implementation.

FIG. 24B is an exploded view of the component parts of the opticalfibers shown in FIG. 24A.

FIG. 25 show top perspective views of the components of a hub accordingto one implementation, the components including a bottom tray, amid-tray, a cover and a gasket.

FIG. 26 is an enlarged view of the bottom tray of FIG. 25.

FIGS. 27A and 27B are enlarged perspective views of the top and bottomof the mid-tray of FIG. 25, respectively.

FIG. 28 is an enlarged view of the cover of FIG. 25.

FIG. 29 is an enlarged view of the gasket of FIG. 25.

FIG. 30 is a perspective view of a partially assembled hub according toone implementation.

FIG. 31 is a perspective view of the hub of FIG. 30 with a coverpositioned to protect the optical fibers running through the hub.

FIG. 32 shows an elongate beading used to form a conduit within the hub.

FIG. 33 is a perspective view of a partially assembled hub according toanother implementation.

FIG. 34 is a perspective view of a central venous catheter with the hubcontaining one or more light reflectors on its outer surface.

FIG. 35A is a top perspective view of a partially assembled hubaccording to one implementation.

FIG. 35B shows the hub of FIG. 35A without the optical fibers.

FIG. 36 is a top view of the hub shown in FIG. 35A.

FIG. 37 is a top perspective view of a mid-tray according to oneimplementation.

FIG. 38 is a cross-section side view of the hub shown in FIG. 35A.

FIGS. 39A-D are perspective views of a partially constructed hub of acentral venous catheter according to other implementations.

FIG. 40 illustrates a partially constructed hub of a central venouscatheter according to another implementation.

FIG. 41 shows a fixture for routing optical fibers within the hub ofFIG. 40

FIG. 42 is a perspective view of a partially constructed hub of acentral venous catheter according to another implementation.

FIG. 43 is a transparent view of a manifold of the hub of FIG. 43 havinginternal conduits that are fluidly coupled to the working lumens of themain shaft.

FIG. 44 is a perspective view of the distal side of the manifold of FIG.43.

FIGS. 45A and 45B show perspective views of a manifold adapter accordingto one implementation.

FIG. 46 shows mandrels being supported inside an infusion shaft supportfixture and the manifold adapter of the hub of FIG. 42.

FIG. 47A shows a proximal side of the infusion shaft support fixture ofFIG. 46.

FIG. 47B shows a distal side of the infusion shaft support fixture ofFIG. 46.

FIG. 48A is a perspective side view of an end emitting fiber having anend cap.

FIG. 48B is a cross-section view of the end emitting fiber of FIG. 48A.

DETAILED DESCRIPTION

FIG. 1A is a schematic side view of a radially emitting fiber with aplurality of voids in the core of the radially emitting optical fiber 12having a central axis 16. FIG. 1B is a schematic cross-section of aradially emitting optical fiber 12 as viewed along the direction 1B-1Bin FIG. 1A. Radially emitting fiber 12 can be, for example, an opticalfiber with a nano-structured fiber region having periodic ornon-periodic nano-sized structures 32 (for example voids). In an exampleimplementation, fiber 12 includes a core 20 divided into three sectionsor regions. These core regions are: a solid central portion 22, anano-structured ring portion (inner annular core region) 26, and outer,solid portion 28 surrounding the inner annular core region 26. Acladding region 40 surrounds the annular core 20 and has an outersurface. The cladding 40 may have low refractive index to provide a highnumerical aperture. The cladding 40 can be, for example, a low indexpolymer such as UV or thermally curable fluoroacrylate or silicone.

An optional coating 44 surrounds the cladding 40. Coating 44 may includea low modulus primary coating layer and a high modulus secondary coatinglayer. In at least some implementations, coating layer 44 comprises apolymer coating such as an acrylate-based or silicone based polymer. Inat least some implementations, the coating has a constant diameter alongthe length of the fiber.

In other exemplary implementations, coating 44 is designed to enhancethe distribution and/or the nature of radiated light that passes fromcore 20 through cladding 40. The outer surface of the cladding 40 or theof the outer of optional coating 44 represents the sides 48 of fiber 12through which light traveling in the fiber is made to exit viascattering, as described herein.

A protective jacket (not shown) optionally covers the cladding 40.

In some implementations, the core region 26 of radially emitting fiber12 comprises a glass matrix 31 with a plurality of non-periodicallydisposed nano-sized structures (e.g., voids) 32 situated therein, suchas the example voids shown in detail in the magnified inset of FIG. 1B.In another example implementation, voids 32 may be periodicallydisposed, such as in a photonic crystal optical fiber, wherein the voidsmay have diameters between about 1×10-6 m and 1×10-5 m. Voids 32 mayalso be non-periodically or randomly disposed. In some exemplaryimplementations, glass 31 in region 26 is fluorine-doped silica, whilein other implementations the glass may be an undoped pure silica.

The nano-sized structures 32 scatter the light away from the core 20 andtoward the outer surface of the fiber. The scattered light is thendiffused through the outer surface of the fiber 12 to provide thedesired illumination. That is, most of the light is diffused (viascattering) through the sides of the fiber 12 and along the fiber lengthwithout the need to remove any portion of the cladding 40.

According to some implementations the nano-sized structures 32 areformed in the cladding 40 of the fiber in lieu of or in conjunction withproviding nano-sized structures in the core 12.

According to some implementations the core 20 has a diameter in therange of 125-300 μm and the overall diameter of the fiber system,including the protective jacket, is in the range of 700 to 1200 μm.According to some implementation, the outer diameter of the fiber 12without a jacket is in the range of 200-350 μm.

A detailed description of exemplary radially emitting optical fibers maybe found in Reissue Pat. No. RE46,098 whose content is incorporatedherein by reference in its entirety.

An example of a radially emitting optical fiber is the Fibrance® LightDiffusing Fiber manufactured by Corning® Incorporated located inCorning, N.Y. The Fibrance® Light Diffusing Fiber has many of theattributes of the radially emitting fiber 12 described above. Anadvantage of the Fibrance® Light Diffusing Fiber is that it emits lightessentially along its entire length and has a small functional bendradius of around 5 millimeters which allows it be easily bent to assumea host of shapes. Breakage of the fiber typically occurs when it is bentto a bend radius of less than about 2 millimeters.

Radially emitting fibers like those disclosed in Reissue Pat. No.RE46,908 do not require the removal of a light reflective component orlight reflective element to enable the emission of light radially fromthe optical fiber.

An end emitting optical fiber is an optical fiber that emits light froma terminal end of the fiber. Such emitted light is referred to herein as“end emitted light” A multimode optical fiber 50, like that shown inFIG. 2, is one example of an end emitting optical fiber wherein light isguided down the center of the fiber through the core 51 and out the endthereof. The fiber 50 includes a core 51 surrounded by a cladding 52.The cladding 52 has a lower index of refraction than the core 51 andtraps the light in the core using an optical technique called “totalinternal reflection.” The fiber 50 itself may include a coated “buffer”to protect the fiber from moisture and physical damage. The core 51 andcladding 52 are usually made of ultra-pure glass, although some fibersare all plastic or a glass core and plastic cladding. According to someimplementations the core 51 has a diameter in the range of 50-250 μm andthe diameter of the cladding 52 is typically around 100-500 μm. Theoverall diameter of the fiber system, including the buffer coating 53,is typically around 150-750 μm. Breakage of the fiber typically occurswhen it is bent to a bend radius of less than about 2 millimeters.

A “transport fiber” as used herein, refers to an optical fiber thattransports light longitudinally through its core to an end of the fiberwith little loss. That is, the vast majority (e.g., ≥90%) of the lightfed into a proximal end of the transport fiber is delivered to theterminal end of the fiber. As explained in more detail below, transportfibers are used in a variety of the implementations disclosed andcontemplated herein to couple a light source (e.g., a laser) to aradially emitting optical fiber and/or end emitting fiber. According tosome implementations, the transport fibers disclosed herein aremultimode optical fibers.

It is important to note that a radially emitting optical fiber, like theexamples discussed above, may also emit light from the core 20 at aterminal end of the radially emitting optical fiber 12. Thus, accordingto some implementations a disinfecting of a device may occur as a resultof bacterial disinfecting light being emitted from both thecircumference and the end of a radially emitting fiber. An opticalfibers designated for this use is referred to herein as a “dual emittingfiber”.

Blue light and ultra-violet light have been shown to kill or curtail thegrowth of certain types of unwanted bacteria that is hazardous andpotentially fatal to mammalian life. Examples of such bacteria areStaphylococcus aureus, Pseudomonas aeruginosa, Leuconostocmesenteroides, Bacillus atrophaeus, Escherichia coli, Coagulase-negativestaphylococci etc. In treatments involving a mammal, blue light ispreferred over ultra-violet light due to detrimental effects ofultra-violet light on mammalian cells and possible damage to hosttissue. In accordance with some implementations disclosed herein bluelight at a wavelength of between 380-495 nm and an exposure of between100-1,000 Joules/cm² is employed to kill the unwanted bacteria.According to other implementations, ultra-violet light at a wavelengthof 100-400 nm and exposure up to 6 J/cm² is employed to kill unwantedbacteria.

It is important to note that the present disclosure is in no way limitedto the use of blue light and ultra-violet light to kill unwantedbacteria. As briefly explained above, the present disclosurecontemplates the use of any type of light that is susceptible to killingunwanted bacteria.

FIG. 3 illustrates a central venous catheter (CVC) 100 that will serveas an exemplary device in which light emitting optical fibers are usedto disinfect one or both of the internal and external surfaces of thedevice. It will become evident in the forthcoming disclosure that manyof the same principles employed in the CVC example are equallyapplicable to a host of other medical and non-medical devices.

A CVC, also called a central line, a long, thin, polymeric, flexibletube (referred to herein as the “main shaft”) used to deliver medicines,fluids, nutrients, or blood products to a venous system of a patientover a long period of time, usually from days up to several weeks ormore. The main shaft is often inserted into the arm or chest through theskin into a vein. The main shaft is typically threaded through this veinuntil it reaches a larger vein, such as, for example, a large vein nearthe heart.

According to some implementations one or more or all of the lightemitting optical fibers that pass through the CVC are unjacketed opticalfibers that include only a core and a cladding. This reduces thediametric profile of the optical fibers that allows them to be morereadily integrated into a CVC, or other types of devices, withoutsubstantially altering the manner in which the CVC is traditionallyused. In this way, established clinical practices may be followed. Thelower diametric profile also beneficially enables the parts of the CVCto be scaled to a smaller size.

FIG. 3 depicts a perspective view of a CVC 100 according to oneimplementation. In this implementation the CVC includes a main shaft 200having three working lumens (see FIGS. 4A, 5A and 5B) through whichdifferent types of therapeutic agents may be delivered to the patient.The working lumens may also serve as conduits for receiving other typesof medical instruments such as, for example, a guidewire that is used toguide the distal end portion of the main shaft 200 to a desired locationin the venous system.

In the example of FIG. 3, the CVC 100 includes three infusion shafts 300having working lumens 308 that are fluidly and respectively coupled tothree working lumens 201 a, 201 b and 201 c of the main shaft 200through a hub 400. That is, the lumen 308 of each of the infusion shafts300 is separately fluidly coupled to one of the working lumens of themain shaft 200. The main shaft 200 of the CVC 100 may comprise more orfewer working lumens with there being a corresponding number of infusionshafts. For example, the main shaft 200 of the CVC 100 may have one, twoor four working lumens with a corresponding one, two or four infusionshafts 300.

A light delivery umbilical 500 comprising one or more transport fibersmay be provided to transport light from a light source to one or moreoptical fibers disposed in one or more of the main shaft 200, infusionshafts 300 and hub 400. The light delivery umbilical 500 may include oneor more proximal connectors 501 to couple one or more light sources tothe one or more transport fibers.

What follows is a detailed description of exemplary implementations ofeach of the main shaft 200, infusion shafts 300, hub 400, light deliveryumbilical 500 and laser system.

FIG. 4A illustrates a cross-sectional view of a main shaft 200 of a CVCaccording to one implementation. As discussed above, according to someimplementations the main shaft 200 includes first, second and thirdworking lumens 201 a, 201 b and 201 c, respectively. According to someimplementations, as shown in FIG. 4B, the inlet 202 a of the firstworking lumen 201 a is located at the proximal end 203 of the main shaft200, whereas the inlets 202 b and 202 c of the second and third workinglumens 201 b and 201 c, respectively, are located a distance distal toproximal end 203 of the main shaft 200. According to otherimplementations one or both of the inlets 201 b and 201 c are located atthe proximal end 203 of the main shaft 200.

In the implementation of FIG. 4A, the working lumens 201 a-c have exitports located at different longitudinal locations of the main shaft. Inthe example of FIG. 4C the exit ports are denoted by reference numbers210, 211 and 212 with the distal exit port 212, intermediate exit port211 and proximal exit port 210 being respectively associated withworking lumens 201 a, 201 b and 201 c.

According to some implementations the main shaft 200 also includes adisinfecting fiber lumen 204 wherein which resides a radially emittingfiber 205 that is capable of emitting bacterial disinfecting light.According to some implementations the disinfecting fiber lumen 204originates at the proximal end 203 of the main shaft 200 and extendsdistally along at least a portion of the length of the main shaft. Theradially emitting fiber 205 enters the disinfecting fiber lumen 204 atthe proximal end 203 of the main shaft 200 and runs the entire length ora portion of the length of the disinfecting fiber lumen 204. Althoughnot required, the disinfecting fiber lumen 204 is preferably placed inbetween the working lumens 201 a-c as shown in FIG. 4A. In theimplementation of FIG. 4A at least a portion of the wall 212 that formsthe disinfecting fiber lumen 204 protrudes into each of the lumens 201a-c. This reduces or eliminates altogether the existence of shadowsbeing cast into the working lumens 201 a-c by virtue of the fiber lumen204 protruding into the working lumens. The main shaft 200 is a flexibleextruded polymer that is transparent or translucent to the light emittedby the radially emitting fiber 205 so that light energy that emanatesradially from the radially emitting fiber 205 is able to pass throughoutthe working lumens 201 a-c and surfaces of the main shaft to disinfectthe interior of the working lumens, including the walls that form them,and the exterior surface 209 of the main shaft.

According to some implementations multiple radially emitting fibers 205are used to disinfect the main shaft 200. In such instances the fibersmay be bundled together inside a common disinfecting fiber lumen or mayreside in multiple disinfecting fiber lumens dispersed within the mainshaft 200.

The main shaft 200 may optionally be provided with an imaging lumen 206that is configured to accommodate another light emitting optical fiber207, hereinafter referred to as the “imaging fiber”. As will bediscussed in detail below, these elements, in addition to radialopenings 208 in the main shaft 200, form a part of a detection systemthat may be used to detect biofilm buildup and/or clot formation on theexternal surface 209 of the main shaft.

According to some implementations of the CVC the main shaft 200 hasneither a radially emitting fiber nor an imagining fiber.

According to some implementations the main shaft 200 comprises anelongate proximal end portion 220 that contains the disinfecting fiberlumen 204 and/or imaging lumen 205. As will be discussed in more detailbelow, the elongate proximal end portion 220 facilitates a routing ofthe radially emitting fiber 205 and/or imaging fiber 207 into the mainshaft 200 via the hub 400. As will be discussed in more detail below,the hub 400 of the CVC is typically encapsulated by a casting material.The end portion 220 serves to prevent the optical fibers from being castinside the casting material so that the optical fibers maintain afreedom of movement within the hub.

FIGS. 5A and 5B illustrate cross-sectional views of a main shaft 200according to other implementations. In the implementation of FIG. 5A thedisinfecting fiber lumen 204 is centrally located sharing a central axis215 with main shaft 200 while in the implementation of FIG. 5B thedisinfecting lumen 204 is located apart from the central axis 215 of themain shaft and runs axially parallel with the central axis along atleast a portion of the length of the main shaft.

Because the imaging fiber 207 must optically communicate through theradial openings 208 located about the circumference of the main shaft200, the imaging lumen 206 is located nearer to the exterior surface 209of the main shaft than to the central axis 215 of the main shaft asshown in each of FIGS. 4A, 5A and 5B. As stated above, a detaileddescription of the configuration and function of these elements isprovided below.

As explained above, optical fibers typically comprise cylindrical glassor plastic cores through which light is transported. The core runs alongthe fiber's length and is surrounded by a medium with a lower index ofrefraction, typically a cladding of a different glass, or plastic. Thecore and cladding of an optical fiber are susceptible to breaking ifexcessively stressed. To address this issue, according to someimplementations the disinfecting fiber lumen 204 diameter is sized to belarger than the outer diameter of the radially emitting optical fiber205 so that the optical fiber 205 is capable of sliding inside thedisinfecting fiber lumen when the main shaft 200 is bent. This reducesor eliminates altogether the occurrence of tensile stresses in theoptical fiber 205 To this end, according to some implementations thedisinfecting fiber lumen 204 has diameter that is up to 30% greater thanthe outer diameter of the radially emitting fiber 205.

According to some implementations the main shaft 200 is formed via anextrusion process. In such implementations the radially emitting fiber205 may be co-extruded with the shaft so that at the end of theextrusion process the fiber 205 resides in the disinfecting fiber lumen204. According to a first co-extrusion process the disinfecting fiberlumen 204 is formed to have an inner diameter that is greater than theouter diameter of the radially emitting fiber 205. This allows the fiber205 to slide inside the disinfecting fiber lumen 204 as described above.This has an impact of reducing tensile and bending stresses producedwithin the radially emitting fiber 205 when the main shaft 200 is bentin comparison to stresses that would exist if the fiber 205 werelongitudinally fixed in the disinfecting fiber lumen 204.

Notwithstanding the foregoing, according to a second co-extrusionprocess the disinfecting fiber lumen 204 is formed to have an innerdiameter that is equal to the outer diameter of the radially emittingfiber 205 with the fiber being fixed in the disinfecting fiber lumen.

In use, the CVC is periodically manipulated by a clinician. Thismanipulation can result in a bending and/or elongation of the main shaftand infusion shaft. In instances when the main shaft and/or infusionshaft contain an optical fiber, this bending and/or elongation of theshaft will induce bending and tensile stresses in the optical fiber.According to some implementations the main shaft 200 is constructed tolimit or prevent its bending beyond a minimum bending radius of theradially emitting fiber 205. (Features for controlling tensile stressesin the optical fiber are discussed below.) The minimum bending radiusmay be that established by a manufacturer of the fiber 205. The minimumbending radius may be associated with a function limit or a breakinglimit of the optical fiber. A functional minimum bending radius may bespecified by the manufacturer of the optical fiber to denote a bendingradius of the optical fiber beyond which the optical fiber is unable toproperly function. A breakage minimum bending radius may be specified bythe manufacturer of the optical fiber to denote a bending radius beyondwhich a breaking of the core and/or cladding occurs. Alternatively, thefunctional minimum bending radius may simply be considered to be anactual bending radius of the radially emitting fiber 205 beyond whichthe optical fiber is unable to properly function and the breakageminimum bending radius may be considered the actual bending radius ofthe radially emitting fiber 205 beyond which a breaking of the coreand/or cladding occurs. The term “minimum bending radius” as used hereinrefers to any one of the aforestated definitions. To achieve a desiredminimum bending radius of the main shaft 200 the material used toconstruct the main shaft may be selected to have a durometer thatimpedes a bending of the shaft beyond the minimum bending radius. Inconjunction with or independent from the material selection, thethickness and geometry of the various walls of the main shaft 200 may beselected to achieve, or assist in achieving, the desired minimum bendingradius. Stiffeners (e.g. a coil, mandrel, braiding, etc.) may also beembedded in the main shaft or otherwise attached to the main shaft toachieve the same objective.

According to some implementations the main shaft 200 is: 1) constructedso that the radially emitting fiber 205 is able to slide within thedisinfecting lumen 204, and 2) constructed to limit or prevent the mainshafts from bending beyond a minimum bending radius of the radiallyemitting fiber 205.

As discussed above, according to some implementations the radiallyemitting fiber 205, which includes both the core and cladding, iscoextruded with the main shaft 200. According to other implementationsthe radially emitting optical fiber 205 is constructed by coextruding alight transmitting core with the main shaft 200 with the shaft materialthat surrounds the core acting as the fiber cladding. According to suchimplementations the core abuts the material that surrounds it.

According to some implementations at least a portion of the outersurface 209 of the main shaft 200 is equipped with a reflector that isconfigured to reduce or impede a loss of light emitted through the mainshaft by fiber 205. This occurs by the reflector reflecting light thatwould otherwise escape the main shaft back into the main shaft. Thereflector may comprise a light reflective coating on the externalsurface of the main shaft, a light reflective film wrapped about atleast a portion of the external surface of the main shaft (e.g. a filmheat shrunk on the outer surface of the main shaft), one or more lightreflective elements embedded in the walls that form the working lumens201 a-c, etc.

As illustrated in the figures, according to some implementations thediameter and/or cross-sectional area of the disinfecting radiallyemitting fiber 205 is smaller than the diameter and/or cross-sectionarea of each of the working lumens 201 a-c of the main shaft 200. Asalso shown in the figures, according to some implementations no portionof the working lumens 201 a-c is encircled by fiber 205.

Catheters in vivo are susceptible to the hazard of blood clot andbiofilm formation on the external surface of the catheter. In the caseof venous catheters, the blood clot or biofilm may break free from thecatheter to create an embolization downstream which can result inserious harm or even death. In the case of urinary catheters, biofilmbuild up leads to patient discomfort.

To address this issue, according to some implementations the main shaft200 comprises an ability to detect biofilm and/or blood clot formationon the exterior surface 209 of the shaft by use of an optical baseddetection system like that illustrated in FIGS. 7A and 7B. The opticalbased detection system 250 is configured to detect short pulse widthback reflections of light 255 reflected off a biofilm and/or blood clotor other unwanted substance residing on the external surface 209 of themain shaft 200. According to some implementations the detection isaccomplished by radially emitting light from the imaging fiber 207through a plurality of through holes 208 located between the imagingfiber and the exterior surface 209 of the main shaft 200. According tosome implementations the portion of the imaging fiber 207 disposed inthe distal section of the main shaft is located near the exteriorsurface 209 of the main shaft in a spiral fashion as shown in FIG. 6.According to such an implementation the through holes 208 are alsospirally dispersed intermittently about the distal section of the mainshaft 200, as also shown in FIG. 6, with each through hole 208 beinglongitudinally spaced from an adjacent through hole. Light deliveredinto the through holes 208 is reflected back into the through holes 208and delivered to a back reflectance detector 252 as shown in FIG. 7B.The arrival time and amplitude of the light reflected back will dependon the location, density, thickness and mass of the biological tissuefrom which it is reflected. According to some implementations theimaging fiber 207 is fixed inside the main shaft 200.

Pulsed light 254 is delivered to the imaging fiber 207 from a lightsource 251 through a beam splitter 253. The light source 251 istypically a laser. The same beam splitter 253 is used to direct the backreflected light pulses 255 to the back reflectance detector 252. Thepulse width of the light and the longitudinal distance between thethrough holes 208 in the main shaft 200 are selected such that the pulsewidth is shorter than the time taken by the light to travel between thethrough holes. As a result, pulsed back reflective light 255 can beconsecutively collected through the through holes 208, beginning withthe proximal-most through hole 208 and ending with the distal-mostthrough hole 208, and delivered to the back reflectance detector 252without colliding with one another. The back reflectance detector 252identifies the through hole from which the back reflected light pulsesoriginate by the order in which it receives the back reflected lightpulses. The back reflectance detector 252 converts the back reflectedlight pulses 255 into electrical signals that are quantified intodigital data that may be processed by a computer processor. According tosome implementations a computer processor is provided in the backreflectance detector itself, while in other implementations theprocessor is located outside the back reflectance detector.

Upon the train of back reflected light pulses 255 having been receivedby the back reflectance detector 252, data associated with these pulsesis processed by a software algorithm implemented by the processor todetermine whether or not a biofilm, clot or other unwanted substance hasformed on the exterior surface 209 of the main shaft 200. This can beachieved by comparing a baseline set of data representative of a cleanouter exterior surface 209 of the main shaft 200 with the datacollected. If the collected data differs from the baseline set of datain a particular way, the software algorithm may determine that a biofilmand/or clot exists on the outer surface of the main shaft.

According to some implementations the data is stored in a computerreadable memory and the software algorithm compares the collected datacollected with the stored data to determine if a biofilm or clot exists.

According to other implementations, and/or in conjunction with one ormore of the processing methods described above, a software algorithm mayprocess the collected data to form an image that can be used todetermine the existence of a biofilm and/or clot on the outer surface209 of the main shaft 200.

In accordance with any of the comparison methods disclosed above, acontrol unit 259 of the detection system may be configured toautomatically activate the light source 251 to initiate a disinfectionof the main shaft 200 upon the control unit determining or beinginformed of an unwanted substance existing on the outer surface of 209of the main shaft 200.

According to some implementations the imaging fiber 207 is an opticalfiber in which selected portions of the cladding have been removed atthe site of the through holes 208 in the main shaft 200. Light isdelivered from the fiber into and through the through holes 208 of themain shaft 200 via the holes formed in the cladding. According to otherimplementations the imaging fiber 207 comprises a radially emittingfiber 205 like those described above. According to such implementationsthe radially emitting fiber may possess an outer most layer (e.g. ajacket) having a plurality of strategically placed apertures that arecircumferentially disposed about the radially emitting fiber 207. Lightis delivered from the fiber 207 into and through the holes 208 in themain shaft 200 via the apertures formed in the outer most layer.

An advantage of the optical based detection systems disclosed herein isthat they do not require a mechanical rotation and translation of theimaging fiber 207 to obtain three-dimensional data pertaining to theouter surface condition of the main shaft.

The introduction of fluids or treatment instruments into the workinglumen or lumens of a CVC occurs via the use of one or more infusionshafts that are in fluid communication with the one or more workinglumens of the main shaft. As discussed above, in the example CVC 100 ofFIG. 3 there are three infusion shafts 300 that each have a workinglumen 308 that is respectively in fluid communication with the first,second and third working lumens 201 a, 201 b, 201 c of the main shaft200. According to some implementations communication between the workinglumens 308 of the infusion shafts 300 and the working lumens of the mainshaft 200 occurs via conduits formed in the hub 400. A detaileddescription of various implementations of the hub 400 is provided below.

FIG. 8A illustrates an external perspective view of an infusion shaft300 according to one implementation. FIG. 8A also depicts an infusionclamp 340 disposed on the infusion shaft 300 that is used to clamp downon the tubular body 303 of the infusion shaft 300 to occlude flowthrough the infusion shaft. A more detailed description of the infusionclamp 340 is provided below.

FIG. 8B is an exploded view of the infusion shaft 300 of FIG. 8A(without the infusion clamp 340) that shows a partial view of a radiallyemitting fiber 301 and an end emitting fiber 302 that extend along atleast a portion of the length of the infusion shaft. As will bediscussed in more detail below, the radially emitting fiber 301 and endemitting fiber 302 are used to deliver disinfecting light, such as bluelight, to the infusion shaft 300 and/or proximal connector 304.

According to some implementations the infusion shaft 300 possesses onlyone of a radially emitting fiber 301 and an end emitting fiber 302.According to other implementations the infusion shaft possesses neithera radially emitting fiber nor an end emitting fiber.

In the example of FIGS. 8A and 8B the infusion shaft 300 includes thetubular body 303 that is connected at its proximal end to a connector304. According to some implementations radially extending barbs 305 areprovided on the distal end portion of the connector 304 to facilitate anattachment of the tubular body 303 to the connector 304. A removable cap306 is connected to a proximal end of the connector 304 via a threadedconnection. As used herein, the cap 306 is considered to be a part ofthe proximal connector 304. A strain relief element 307 may also beprovided at the junction of the tubular body 303 and the connector 304.

FIG. 9A is a cross-section view of the tubular body 303 according to oneimplementation. The tubular body 303 comprises an extruded polymericstructure having walls that define a working lumen 308, a radiallyemitting fiber lumen 309 configured to house the radially emitting fiber301, and an end emitting fiber lumen 310 configured to house the endemitting fiber 302. According to some implementations the radiallyemitting fiber lumen 309 and end emitting fiber lumen 310 are at leastpartially located in a key portion 311 of the polymeric structure of theinfusion shaft 300 with the radially emitting fiber lumen 309 beinglocated adjacent the working lumen 308. According to someimplementations the radially emitting fiber lumen 309 is defined by awall segment 312 that protrudes into the working lumen 308 as shown inFIG. 9A. According to such an implementation the radially emitting fiberlumen 309 may, but not necessarily, overlap with a portion of theworking lumen 308 for the purpose of maximizing the dispersion of thedisinfecting light inside the working lumen when the radially emittingfiber 301 is illuminated. This maximization occurs, at least in part, asthe result of no shadows being cast into the working lumen 308 by virtueof the wall segment 312 protruding into the working lumen 308 and/or anoverlapping of fiber lumen 309 with the working lumen 308.

As illustrated in the figures, according to some implementations thediameter and/or cross-sectional area of each of the radially emittingfiber 301 and end emitting fiber 302 is smaller than the diameter and/orcross-section area of the working lumens 308 of the infusion shaft 300.As also shown in the figures, according to some implementations noportion of the working lumen 308 is encircled by either of fibers 301and 302.

As explained above, the core and cladding of an optical fiber aresusceptible to breaking if excessively stressed. To address this issue,according to some implementations the diameter of the radially emittingfiber lumen 309 is sized to be larger than the outer diameter of theradially emitting optical fiber 301 so that the optical fiber is capableof sliding inside the radially emitting fiber lumen 309 when theinfusion shaft 300 is bent. To this end, according to someimplementations the radially emitting fiber lumen 309 has diameter thatis up to 30% greater than the outer diameter of the radially emittingfiber 301.

To facilitate a closing off of the working lumen 308 by use of the clamp340, portions 313 of the sidewalls that form the working lumen have areduced thickness t1 as compared to the remaining portions of walls thatdefine the working lumen 308. The reduced thickness portions 313 areengineered to act as hinges that promote a collapsing of the tubularbody 303 on itself when the clamp 340 is caused to exert a force Fagainst a compression wall 314 that is located opposite the key portion311. According to some implementations the compression wall 314 includesa recess 315 that is configured to mate with the protruding wall segment312. The mating of the parts 312 and 315 promotes an ordered closure ofthe working lumen 308 in a manner that assists in inhibiting a twistingof the tubular body 303 when the clamp 340 acts to close the workinglumen.

The key portion 311 of the infusion shaft 300 serves a number offunctions. It provides a region that is located outside, orsubstantially outside, the working lumen 308 for housing the radiallyand end emitting fibers 301, 302. This is important because if thefibers 301, 302 were to be located outside the key portion 311, theywould be susceptible to breakage when the tubular body 303 is clamped toeffectuate a closing of the working lumen 308. A further advantage ofhousing the fibers 301, 302 in the key portion 311 of the tubular body303 is that accessibility to and through the working lumen 308 of theinfusion shaft 300 remains the same or similar to that of conventionalCVC systems.

As will be described in more detail below, the key portion 311 can alsobe configured to reside within a groove 346 of a lower pad 342 of theclamp 340 in order to maintain the tubular body 303 properly oriented inthe clamp to ensure the upper pad 341 of the clamp properly acts on thecompression wall 314 during the clamping procedure. This prevents orinhibits a twisting of the tubular body 303 during the clampingprocedure that could otherwise result in a breaking of the fibers 301,302.

As explained above, stresses produced within an optical fiber (e.g., aradially emitting optical fiber and/or an end emitting optical fiber)can be caused by a bending of the fiber. For this reason, according tosome implementations the infusion shaft 300 is constructed to limit orprevent its bending beyond a minimum bending radius of one or both ofthe radially emitting fiber 301 and end emitting fiber 302.

As discussed above in conjunction with the description of the main shaft200, optical fibers typically have a functional minimum bending radiusbeyond which the fibers are unable to properly function and a breakageminimal bending radius beyond which a breaking of the core and/orcladding occurs. The functional and/or breakage minimum bending radiusmay be specified by the manufacturer of the optical fiber. Thefunctional and/or breakage minimum bending radius may alternatively beconsidered the actual bending radius of the optical fiber beyond whichthe optical fiber is unable to properly function or which a breaking ofthe core and/or cladding occurs. To achieve a desired minimum bendingradius of the infusion shaft 300 the material used to construct theinfusion shaft may be selected to have a durometer that impedes abending of the shaft beyond the functional or breakage minimum bendingradius of one or both of the radially emitting fiber 301 and the endemitting fiber 302. In conjunction with or independent from the materialselection, the thickness and geometry of the various walls of theinfusion shaft 300 may be selected to achieve, or assist in achieving,the desired function or breakage minimum bending radius. Moreover, astiffening of the infusion shaft 300 may occur by embedding one or morestiffening elements (e.g. a coil, mandrel, braiding, etc.) inside thekey portion 311 along a length of the tubular body 303. According toother implementations a stiffening jacket or other element may beattached to at least a portion of the outer surface of the tubular bodyto obtain a desired stiffness that resists against the fiber 301 and/or302 bending beyond its/their minimum bending radius. Stiffeners (e.g. acoil, mandrel, braiding, etc.) may also be embedded in the main shaft orotherwise attached to the main shaft to achieve the same objective.

Because a majority of the walls of the tubular body 303 that form theworking lumen 308 are engineered to be relatively flexible toaccommodate a closing of the working lumen by the clamp 340, accordingto some implementations a majority of the stiffness attributed to thetubular body 303 is engineered to reside in the key portion 311.According to some implementations this is accomplished by the keyportion 311 having an overall width dimension “w” that is greater thanany of the thickness dimensions of the remainder of the walls that formthe working lumen 308. The shape of the key portion 311, for example arectangular shape, can also contribute to its stiffness.

With reference to FIGS. 9A and 9B, according to one implementation thedimensions of the tubular body 303 are as follows. The overall height“h₁” is 3.055 millimeters with a horizontal centerline of the workinglumen 308 residing 1.850 millimeters above the bottom end of the tubularbody as denoted by the reference “h₂”. The key portion 311 has a height“h₃” and a width “w”, each of which are 1.000 millimeters. Thecenterline of the end emitting fiber lumen 310 is located a height “h₄”of 0.425 millimeters above the bottom end of the tubular body 303. Eachof the walls of the tubular body that form the hinge portions 313 have athickness “t₁” of 0.125 millimeters. The wall thickness dimensions “t₂”and “t₃” are 0.250 millimeters and 0.100 millimeters, respectively. Thedistance “d” between the central axis of the radially emitting fiberlumen 309 and the horizontal centerline of the working lumen 308 is0.850 millimeters. The diameter of each of the radially emitting fiberlumen 309 and end emitting fiber lumen 310 is about 0.280 millimeters.Furthermore, the width “w” of the key portion 311 is dimensioned to besmaller than the maximum width dimension of the working lumen 308.

According to some implementations the ratio of h3/h1 is less than 0.6.By limiting the size of the key portion 311 in this way, it limits thedegree by which the infusion shaft 300 differs from traditional infusionshafts. In addition, according to some implementations the ratio oft₁/t₂ is less than 1.0 to yield the creation of hinge portions 313 thatare configured to bend when a force is applied downward on the top endof the infusion shaft 300.

FIGS. 10A-C are cross-section views of example alternative infusionshaft tubular body designs. In the implementation of FIG. 10A theworking lumen 308 of the tubular body 303 has a semi-circularconfiguration that is partially truncated by a structure 320 that housesthe radially emitting fiber lumen 309. The structure 320 extends fromthe key portion 311 that houses the end emitting fiber lumen 310.Clamping the working lumen 308 shut in the direction of arrow A canoccur in a manner like that described above in conjunction with theimplementation of FIG. 9A.

In the implementations of FIGS. 10B and 10C each of the radiallyemitting fiber lumens 309 and end emitting fiber lumen 310 are suspendedin the tubular body 303 by a septum/wall 321 with the radially emittingfiber lumen residing centered in the tubular body. In each of theseimplementations, the infusion shaft is provided with first and secondlumens 308 a and 308 b that are separated by the septum 320. In each ofthese implementations the first and second working lumens 308 a and 308b can be clamped shut by applying an inward force F1 and F2 to the wallsof the tubular body, respectively. In each of the implementations ofFIGS. 10A and 10B first and second wings 321 a and 321 b protrude fromopposite sides of the tubular body and are used to align the tubularbody 303 in a clamp (not shown) that is capable of applying the forcesF1 and F2. According to some implementations the working lumen 308 a isconfigured to transport a fluid and the working lumen 308 b isconfigured to receive a treatment instrument, such as, for example, aguidewire.

As shown in FIG. 10B, the radial emitting fiber lumen 309 is partiallyformed of wall segments on each side of the fiber lumen that protrudeinto the respective first and second lumens 308 a and 308 b. Althoughnot shown in FIG. 10B, according to some implementations the interiorwall 322 of the working lumens 308 a and 308 b each comprise a recessthat is configured to mate with the protruding wall segments of thefiber lumen. The mating of the parts promotes an ordered closure of theworking lumens 308 a and 308 b in a manner that assists in inhibiting atwisting of the tubular body 303 when the clamp 340 acts to close theworking lumens.

According to some implementations the infusion shaft 300 is a flexibleextruded polymer that is transparent or translucent to the light emittedby the radially emitting fiber 301 so that light that emanates radiallyfrom the radially emitting fiber 301 is able to pass through the wallsof the infusion shaft to disinfect the interior walls 322 of the workinglumens 308 a, 308 b.

As stated above, according to some implementations the infusion shaft300 is formed via an extrusion process. In such implementations one orboth of the radially emitting fiber 301 and end emitting fiber 302 maybe co-extruded with the infusion shaft so that at the end of theextrusion process fiber 301 resides in the radially emitting fiber lumen309 and fiber 302 resides in the end emitting fiber lumen 310. Accordingto a first co-extrusion process one or both of the radially emittingfiber lumen 309 and end emitting fiber lumen 310 is formed to have aninner diameter that is greater than the outer diameter of the radiallyemitting fiber 301 and end emitting fiber 302, respectively. This allowsthe fibers 301 and 302 to slide inside their respective lumens. This hasan impact of reducing tensile and bending stresses produced within thefibers when the infusion shaft 300 is bent in comparison to stressesthat would otherwise exist if the fibers were longitudinally fixedinside their lumens. According to some implementations one or both ofthe radially emitting fiber lumen 309 and end emitting fiber lumen 310has diameter that is up to 30% greater than the respective outerdiameter of the radially emitting fiber 301 and end emitting fiber 302.

According to some implementations the infusion shaft 300 is: 1)constructed so that one or both of the radially emitting fiber 301 andend emitting fiber 302 is able to slide within its respective lumen 309and 310, and 2) constructed to limit or prevent the infusion shaft frombending beyond a minimum bending radius associated with one of theradially emitting fiber 301 and end emitting fiber 302.

FIG. 11A shows an implementation of the clamp 340 used to close off flowthrough the infusion shaft 300 with the clamp being in the openposition. FIG. 11C illustrates the clamp of FIG. 11A being in the closedposition. FIG. 11B illustrates the infusion shaft 300 running throughthe clamp of FIG. 11A with the clamp being in the open position.

Because the core and cladding of optical fibers 301 and 302 aresusceptible to breakage when the infusion shaft is bent and/or twisted,according to some implementations the clamp 340 is keyed at its proximaland distal ends to the infusion shaft 300 as shown in FIG. 11B toprevent the shaft from twisting during a closing of the clamp onto theshaft. As discussed above, the groove 346 in the lower pad 342 servesthe same function. To further guard against the breakage of the opticalfibers 301 and 302 during and after the closure of the clamp 340,according to some implementations the upper and lower pads 341 and 342of the clamp are compliant enabling them to at least partially conformto the outer profile of infusion shaft. This has the effect ofdistributing the force applied by the clamp 340 over a larger surfacearea of the infusion shaft 300. According to some implementations theupper pad 341 is assembled on a resilient arm 344 and is moved to theclosing position by the application of a downward force at an end of thearm 344. According to some implementations the clamp 340 is equippedwith a stop that engages the upper pad 341 and/or arm 344. The clamp 340is configured with the stop to limit the amount by which the upper pad341 may be moved downward against the tubular body 303 of the infusionshaft 300. The downward movement of the upper pad 341 is restrainedsufficiently to limit the amount of force it is capable of applying tothe tubular body 303 so as to inhibit or prevent a breaking of one orboth of fibers 301 and 302 while at the same time accommodating aclosing of the infusion shaft lumen 308. As shown in FIG. 11A, accordingto one implementation the stop 354 is in the form of one or more tabsthat protrudes outward from the distal wall 353 of the clamp. The tabs354 a are configured to abut bottom portions 354 b of the arm latch 355to limit downward movement of the arm 344 and upper pad 341.

According to some implementations the clamp 340 includes a base 343 andan arm 344 that are connected by a vertically extending proximal wall345. A hinge 347 provided between the proximal wall 345 and arm 344enables the arm to be resiliently moved downward toward the base 343when a force is applied to the top surface of the arm. Slip resistantgrips 348 and 349 are respectively provided on both the top surface ofthe arm 344 and on the bottom surface of the base 343. According to someimplementations the grips 348 and upper pad 341 comprise a unitarystructure with the grips protruding upward from the upper pad intoapertures formed in the arm 344. Likewise, according to someimplementations the grips 349 and lower pad 342 comprise a unitarystructure with the grips protruding downward from the lower pad intoapertures formed in the base 343.

Keying the clamp 340 to the infusion shaft 300 occurs by a passing ofthe infusion shaft 300 through key openings 350 and 351 in the clamphaving a same or similar profile of the shaft. In the implementation ofFIGS. 11A-C key opening 350 extends through the proximal wall 345 andthrough a proximally extending protrusion 352. Although the proximallyextending protrusion 352 is not required, it advantageously contributesto preventing a twisting of the infusion shaft in the clamp 340 byincreasing the length of the infusion shaft 300 that is restrained. Keyopening 351 is located in a distal wall 353 of the clamp.

A closing of the clamp 340 from an open position to a closed positionoccurs when a downward force is applied to the top surface of arm 344. Adistal end of the arm 344 includes a latch 355 having an upward facingshelf 356 that is configured to engage with a downward facing shelf 357on the distal wall 353 to lock the clamp in a closed position as shownin FIG. 11C. During the closing operation the latch 355 moves downwardalong the distal wall 353 over an outward sloping ramp 359 until theupward facing shelf 356 surpasses the bottom of the ramp and movesinward to rest against the downward facing shelf 357. As the latch 355of the arm 344 passes along the ramp 359, the distal wall 353 of theclamp flexes slightly outward and then attempts to return to itsoriginal position when the upward facing shelf 356 surpasses the bottomof the ramp 359. The resilient nature and configuration of the arm 344and distal wall 353 cause the shelves 356 and 357 to be pressed againstone another to maintain the clamp 340 in a closed position as shown inFIG. 11C.

To return the clamp 340 to its open position a rearward force is appliedto the curved latch release 360 that extends upward from the distal wall353 to flex the distal wall in the direction A as shown in FIG. 11C.This has an effect of sliding the downward facing shelf 357 of thedistal wall 353 off the upward facing shelf 356 of latch 355. When thisoccurs, the arm 44 returns to its biased open position as shown in FIGS.11A and 11B.

According to some implementations the clamp 340 and the proximalconnector 304 of the infusion shaft 300 comprise a unitary structurewith the clamp protruding from the distal end of the proximal connector.According to such implementations the proximal connector 304 and clamp340 may be injection molded as a single piece. The proximal connector isdiscussed in detail below.

As discussed above, the working lumen 308 of the infusion shaft 300 iscoupled to a working lumen of the main shaft 200 through a connectionthat occurs inside the hub 400. A detailed description of the hub 400 isprovided below. In addition, according to some implementations theradially emitting fiber 301 and end emitting fiber 302 are introducedinto the key portion 311 of the infusion shaft 300 via the hub 400.Thus, according to some implementations both the radially emitting fiber301 and end emitting fiber 302 run the entire length of the tubular bodyportion 303 of the infusion shaft 300 as shown in FIG. 12, while inother implementations the radially emitting fiber 301 runs less than theentire length of the tubular body. As discussed above, the tubular body303 is connected to a proximal connector 304 through which therapeuticagents and/or medical instruments are introduced into the infusion shaft300. FIG. 13 shows a perspective view of a proximal end segment 319 ofthe tubular body 303 according to one implementation.

FIG. 14A illustrates a cross-section side view of a proximal connector304 to which the proximal end of the tubular body 303 of FIG. 12 isattached. FIG. 16 is an external perspective view of the proximalconnector of FIG. 14A. FIG. 14B shows a partial cross-section view ofthe proximal connector 304 with the end segment 319 of the key portion311 of the tubular body 303 fully inserted into a receiving lumen 363 ofthe proximal connector. According to some implementations the entiretyof proximal connector is made of a material that is transparent ortranslucent to the light emitted by the radially emitting fiber 301.According to other implementations only selected portions of theproximal connector 304 located adjacent radially emitting fiber 301 ismade of a material that is transparent or translucent to the lightemitted by fiber 301. In either case, the contents and/or walls of atleast a portion of the inner lumen 365 of the proximal connector 304 canbe exposed to the disinfecting light emitted by the radially emittingfiber 301.

In the implementation of FIG. 12 the tubular body 303 comprises theworking lumen 308 and the radially emitting and end emitting fibers 301,302 residing in their respective lumens 309, 310 inside the key portion311 of the tubular body. A proximal end section of the tubular body 303is skived so that the end segment 319 of the key portion 311 extendsproximal to the proximal end of the working lumen 308. The distal end323 of the tubular body 303 that resides inside the hub 400 may also beskived. As shown in FIGS. 12, 14A, and 14B, an end portion 301 a of theradially emitting fiber 301 and an end portion 302 a of the end emittingfiber 302 protrude from the proximal end of the key portion 311 of thetubular body 303 and reside respectively within lumens 361 and 362located in the proximal connector 304. In the implementation of FIG. 14Bthe end portions 301 a and 302 a of the fibers 301 and 302 are shorterthan the respective lumens 361 and 362 they reside in. Although thelength of the fibers 301 and 302 can be selected to cause their ends 301c and 302 c to abut the end walls 361 a and 362 a of the lumens 361 and362, the provision of gaps as shown in FIG. 14B advantageously allowsfor less restrictive tolerances (reducing manufacturing costs) andminimizes the risk of damaging the fibers 301 and 302 when the CVC 100is assembled.

Again with reference to FIG. 14A, the proximal connector 304 furthercomprises features for directing the light 366 emitted from the endemitting fiber 302 into the internal space of the proximal connector.FIG. 15 shows a ray tracing of the light 366 dispersed inside theproximal connector 304 according to one implementation. The lightemitted by the end emitting fiber 302 passes through a first opticalsurface/lens 367 and a second optical surface/lens 368 that act to alterthe trajectory of the light so that it impinges on a light reflector 369positioned on, or otherwise integrated into, a distal facing surface ofa central portion 306 a of the cap 306. According to someimplementations the first and second optical surfaces 367 and 368 havean RMS surface roughness of less than 180 angstroms.

According to some implementations the trajectory of the disinfectinglight is altered as a result of being refracted by each of the first andsecond optical surfaces 367 and 368. Optical surfaces of this type arealso referred to herein as “refractive optical surfaces”. (Refraction isa deflection from a straight path undergone by a light ray or energywave in passing obliquely from one medium (such as air) into another(such as glass) in which its velocity is different.) That portion of theproximal connector 304 residing between the first and second opticalsurfaces is a material that is substantially transparent or at leasttranslucent to the light emitted by the end emitting fiber 302.According to some implementations the material is a Teflon or apolycarbonate.

In the implementation of FIG. 15, the first and second opticalsurfaces/lenses 367, 368 and the light reflector 369 are arranged in theproximal connector 304 to cause the light emitted from the end emittingfiber 302 to flood at least a portion of the length of the inner lumen365 of the proximal connector and/or at least a portion of the innerlumen 308 of the tubular body 303. According to some implementationsthis length of the inner lumen 365 is out of reach of the disinfectinglight emitted by the radially emitting fiber 301. In the implementationof FIG. 15, however, there is an overlapping of the light paths thatemanate from fibers 301 and 302 along at least a portion of the lengthof the inner lumen 365. Thus, when the fibers 301 and 302 are bothilluminated this has an effect of providing not just one, but two dosesof disinfecting light in the overlapping region.

According to some implementations an index matching material, such as agel or adhesive, is positioned in the gap that separates the end 302 cof the end emitting fiber 302 from the end wall 362 a of lumen 362. Theindex matching material is selected to have a refractive index betweenthat of the core of the end emitting fiber 302 and that of the firstoptical surface 367 formed in or located on the end wall 362 a of lumen362. During an assembly of the CVC 100 the index matching material maybe introduced into the gap via a port 370 located in a side of theproximal connector.

The first optical surface/lens 367 resides at the inner surface of theend wall 362 a of lumen 362. According to some implementations the innersurface of the end wall 362 a is of optical quality that minimizes ascattering of the light emitted by fiber 302 so that the vast majorityof the disinfecting light entering the surface/lens 367 is directed ontothe second optical surface/lens 368. In a like manner, the secondoptical surface/lens 368 of optical quality so that a vast majority ofthe disinfecting light that enters the surface/lens 368 is transportedto the cap light reflector 369 and then onto the contents and/or innerwalls of the inner lumen 365 of the proximal connector.

According to some implementations the first optic surface/lens 367 isarranged perpendicular to a longitudinal axis 373 of the proximalconnector 304 and the second optical surface/lens 368 is positioned atan angle relative to the longitudinal axis. The angle by which thesecond optical surface/lens 368 if tilted with respect to thelongitudinal axis 391 is selected to assist in diverting the lightexiting the lens upward toward a selected portion of the cap reflector369. According to some implementations the lens 368 is tilted an angleless than 20 degrees in relation to the plane orthogonal to thelongitudinal axis 391. According to some implementations, like thatshown in FIG. 19A, the second optical surface/lens 368 is dispensed withand the first optical surface/lens 367 is angled to assist in directingthe light emitted by the end emitting fiber 302 to impinge on a locationof the cap light reflector 369 that causes the light to flood at least aportion of the length of the internal lumen 365 of the proximalconnector and/or at least a portion of the internal lumen 308 in thetubular body 303. An exemplary light path of such implementations isshown by the arrows in FIG. 19A. This can occur by bending the distalend portion of the lumen 362 upward so that it is not parallel to thelongitudinal axis 391 of the proximal connector 304 as shown in FIG.19A. In this way a direct optical path between the first opticalsurface/lens 367 and the reflector 369 may be established.

The cap light reflector 369 may comprise any shape that is capable ofcausing the light impinged upon it to be reflected down at least aportion of the inner lumen 365 of the proximal connector 304. Accordingto some implementations the cap reflector 369 comprises a concave orconvex surface having a radius of curvature suitable for establishing adesired light path down the inner lumen 365 of the proximal connector.According to other implementations the reflector 369 may comprise a flatsurface that may or may not be oriented at an angle in relation to thelongitudinal axis 373 of the proximal connector 304. FIG. 18 is aperspective view of the proximal connector cap 306 according to oneimplementation. As also shown in FIG. 14A, the cap 306 has internalthreads 371 that mate with external threads 372 of the proximalconnector that allow that cap to be fixed to and removed from theproximal connector.

As best seen in FIGS. 14A and 17, according to some implementations theproximal connector 304 is equipped with a ramp 373 that is configured tofacilitate an advancement of a medical instrument through the lumen 365of the proximal connector. The medical instrument may be, for example, aguidewire. In the implementation of FIG. 17 the ramp 373 comprises afirst part 373 a and a second part 373 b that reside on opposite sidesof the second optical surface 368 so that there exist a direct line ofsight between the second optical surface/lens 368 and the cap reflector369.

In accordance with some implementations disclosed herein each of theradially emitting fiber 301 and end emitting fiber 302 emits blue lightat a wavelength of between 380-495 nm and an exposure of between100-1,000 Joules/cm2 is employed to kill the unwanted bacteria.According to other implementations fibers 301 and 302 emit ultra-violetlight at a wavelength of 100-400 nm and exposure up to 6 J/cm² to killunwanted bacteria.

In the infusion shaft 300 implementations discussed above, both aradially emitting fiber 301 and an end emitting fiber 302 are used toeffectuate a disinfection of the infusion shaft. However, according toother implementations only one of a radially emitting fiber and an endemitting fiber is used. For example, according to some implementationsdisinfection predominately occurs inside the proximal connector 304 byuse of the end emitting fiber 302 and the radially emitting fiber 301 isdispensed with altogether as shown in FIG. 19A. According to otherimplementations the end emitting fiber 302 is dispensed with and theradially emitting fiber 301 alone is used to disinfect at least aportion of the tubular body 303 and at least a portion of the proximalconnector 304 of the infusion shaft 300 as shown in FIG. 19B. Accordingto implementations that do not include an end emitting fiber theradially emitting fiber 302 may extend proximally inside the proximalconnector 304 to a location near or adjacent the distal end of the cap306 when the cap is fully threaded onto the connector as shown in FIG.19B. In this manner the radially emitting fiber 301 is capable ofdisinfecting a greater length of the proximal connector.

According to some implementations the radially emitting fiber 301 isalso configured to emit light from an end thereof. According to suchimplementations the light emitted from the end of the radially emittingfiber 301 may be delivered to a target location inside the proximalconnector 304 and/or a target location inside the tubular body 303 ofthe infusion shaft by the use of one or more optical surfaces and/or oneor more reflectors similar to the concepts described above and below inconjunction with the examples of FIGS. 14A, 14B, 20A, 20B, 21A and 21B.For example, as shown in FIG. 19C, disinfecting the infusion shaft 300may occur by use of a radially emitting fiber 301 that emits lightradially along its length and also emits light from a distal end of thefiber. Like the implementation of FIG. 19A, an optical surface 367 andreflector 369 may be used to distribute the light emitted from the endof the radially emitting fiber 301 into the proximal connector.

A majority of the light transmitted by a radially emitting fiber istypically emitted radially from the fiber with a smaller amount beingemitted from the end of the fiber. For example, the Fibrance® LightDiffusing Fiber manufactured by Corning® Incorporated has a diffusionlength that is characterized by an emitting of 90% of its light radiallyalong its length with the remaining 10% being emitted from its end.These percentages will vary among different radially emitting fibers andare typically established by the fiber manufacturer. Because it may bedesirable to use the light emitted from the end of the radially emittingfiber to disinfect an object, like in the example of FIG. 19C, thepercentage of light emitted through the end of the radially emittingfiber may be increased by cutting short the length of the fiber. Forinstance, a radially emitting fiber that has a given diffusion lengththat results in 90% of its light being radially emitted with theremaining 10% being emitted from its end can be cut short to cause apercentage increase in the amount of light being emitted from the end.For example, the radially emitting fiber may be cut by a certain lengthto cause a decrease in the amount of light that is radially emitted andan increase in the amount of light that is end emitted. According tosome implementations the radially emitting fiber is cut short to cause50-80% of the light to be radially emitted and correspondingly 50-20% ofthe light to be end emitted.

According to other implementations the radially emitting fiber mayitself be engineered to obtain a desired distribution of light from itssides and end. This can be achieved, for example, by altering the amountof nano-sized structures doped within the fiber. According to someimplementations the radially emitting fiber is engineered to cause50-90% of the light to be radially emitted and correspondingly 50-10% ofthe light to be end emitted. According to other implementations theradially emitting fiber is engineered to cause 50-80% of the light to beradially emitted and correspondingly 50-20% of the light to be endemitted.

It is important to note that multiple radially emitting fibers and/ormultiple end emitting fibers may be used to disinfect the infusion shaft300.

In regard to both the main shaft 200 and the infusion shaft 300, when aradially emitting fiber that emits light from an end thereof is used,the end of the radially emitting fiber may be coated with a reflectivematerial, such as gold, to direct the light that would otherwise be lostout the end of the fiber back into the fiber core. Alternatively, theend of the radially emitting fiber may be fitted within a cap that hasan internal reflective surface that causes at least a portion of thelight emitted from the end of the fiber back into the fiber. Reflectingthe light back into the fiber advantageously increases the amount oflight emitted along the length of the radially emitting fiber.

The laser induced damage threshold, or the ability to propagate light ofa given power density, varies among material types. For example, a fiberoptic core comprised of fused silica glass may have a higher toleranceto laser damage than a polymer. The power density of light emitted by amultimode type end emitting fiber can be high as a result of essentiallythe totality of the light input being emitted from the end of the smalldiameter core. The power densities of the light emitted by the multimodetype end emitting fiber may exceed the capabilities of the materialsselected for injection molded optics or casted hubs. To alleviate thisproblem, according to some implementations the end emitting fiber 302 isequipped with an end cap that reduces the power density of the lightthat leaves the end emitting fiber core.

FIG. 48A shows a perspective side view of an end portion of an endemitting fiber 650 that has an end cap 651 attached to the end of thefiber 650. FIG. 48B shows a cross-section of the end cap according toone implementation. The fiber includes a glass or polymer core 652 and acladding 653 disposed about the core. The end cap 651 includes acylindrical body 654 that houses a medium 655 that is optically coupledto the fiber core 652. The medium is transparent to the light itreceives from the core 652 and has an index of refraction that is thesame or close to that of the fiber core 652. The medium is sized andshaped so that the light that exits the end 656 of the end cap 651 has apower density that is lower than the power density of the light when itleaves the fiber core 652. This is accomplished by widening the lightbeam received from the fiber core. The widening of the light beam occursas a result of the medium having a greater diameter than that of thefiber core. In the example of FIG. 48B, the diameter of the medium 655increases between its proximal and distal ends 657 and 656,respectively. However, according to other implementations the medium maybe cylindrical or spherical in shape. Coupling of the end cap medium 655to the fiber core 652 may occur in several ways. According to one methodthe proximal end of the medium is fused with the fiber core. Accordingto other implementations the medium is formed from the fiber core.

FIG. 9C illustrates a cross-section of the tubular body 303 of aninfusion shaft whereby a curved reflector of light 316 a is embeddedpartially surrounding the radially emitting fiber 301 to direct lightemitted from the sides and bottom of the fiber 301 upward toward theinternal lumen 308. FIG. 9D illustrates a similar configuration whereinthe reflector 316 b comprises a flat profile extending across at least aportion of the width of the key portion 311 of the tubular body 303. Inimplementations that also involve the use of an end emitting fiber 302,the reflector 316 may be located between the radially emitting fiberlumen 309 and the end emitting fiber lumen 310. According to someimplementations the reflectors 316 a and 316 b are embedded into thetubular body 303 of the infusion shaft 300 while the tubular body isbeing extruded via co-extrusion process.

According to other implementations, that may or may not include a lightreflector like that of reflector 316 a or reflector 316 b, at least aportion or all of the peripheral wall of the tubular body 303 is coated,wrapped or impregnated with a material that is light reflective. Thisadvantageously results in light being reflected back into the tubularbody 303 (that would otherwise escape), thereby increasing the lightdensity within the tubular body when the radially emitting fiber isilluminated. In the implementation of FIG. 9E an outer thickness of theperipheral wall 317 of the tubular body 303 is impregnated with lightreflective materials, such as, for example, aluminum particles.According to some implementations the light reflective material isimpregnated into the peripheral wall during the extrusion of the tubularbody 303. In the implementation of FIG. 9F the outer surface of thetubular body 303 is coated or wrapped with a light reflective material318. According to implementations in which the outer surface of thetubular body 303 is wrapped, the wrapping may comprise a heat shrinkhaving light reflective properties that is heat shrunk onto the outersurface. The outer surface of the tubular body 303 may also comprise areflective film, such as a layer of light reflective paint.

According to some implementations at least a portion of the externalsurface of the proximal connector 304 is coated or wrapped with a lightreflective material so that at least a portion of the disinfecting lightdelivered into the internal lumen 365 is reflected back into the lumenwhen the light impinges on the light reflective material. Like thetubular body 303, the proximal connector 304 may be tightly wrapped witha heat shrink that possesses a light reflective material. The externalsurface of the proximal connector 304 may also comprise a reflectivefilm, such as a layer of light reflective paint. The use of the lightreflective material improves internal disinfection and acts to reduce oreliminate an impingement of the disinfecting light onto the skin of thepatient that could otherwise result in patient discomfort in the form ofheat.

In the implementation of FIG. 14A optical surfaces 367 and 368 were usedin conjunction with a light reflector 369 to direct light emitted fromthe end emitting fiber 302 to a target location inside the proximalconnector 304. In addition, each of the optical surfaces 367 and 368were internal to the proximal connector 304. In the implementations ofFIGS. 20A and 21A optical surfaces are used to direct light emitted bythe end emitting fiber 301 to its target location without the use of alight reflector. Moreover, in the implementation of FIG. 21A at leastsome of the optical surfaces reside on and/or in an insert residing in aside cavity of the proximal connector 304. According to someimplementations one or more or all of the optical surfaces has an RMSsurface roughness of less than 180 angstroms.

In each of the implementations disclosed and contemplated herein, whenan end emitting fiber is used to deliver bacterial disinfecting light toa target location the end emitting fiber may be equipped with an endcap.

FIG. 19D illustrates an implementation in which an end cap 651 isattached to the end of an end emitting fiber 302 and used to deliverlight 659 directly to the light reflector 369 of end cap 306 without theuse of an optical surface. That is, no structure exits between the endof the end cap and the light reflector 369 of the end cap 306. Thisarrangement results in a more simple design and can increase theefficiency by which light id delivered to its target location inside theproximal connector 304 and/or tubular body 303 of the infusion shaft.

Each of the implementation of FIGS. 20A and 21A is similar to that ofFIG. 14A except that no light reflector 369 is provided on the cap 306.Instead, to reflect the light these implementations use one or moreoptical surfaces on which total internal reflection occurs. These typesof optical surfaces are also referred to herein as “total internalreflection optical surfaces”.

Total internal reflection is the phenomenon which occurs when apropagated wave strikes a medium boundary at an angle larger than aparticular critical angle normal to the incident surface. If therefractive index is lower on the opposing side of the boundary and theincident angle is greater than the critical angle, the wave cannot passthrough and is entirely internally reflected. The critical angle is theangle of incidence above which the total internal reflection occurs.This is particularly common as an optical phenomenon, where light wavesare involved.

When a wave reaches a boundary between different materials withdifferent refractive indices, the wave will in general be partiallyrefracted at the boundary surface, and partially reflected. However, ifthe angle of incidence is greater (i.e. the direction of propagation iscloser to being parallel to the boundary) than the critical angle—theangle of incidence at which light is refracted such that it travelsalong the boundary—then the wave will not cross the boundary, but willinstead be totally reflected back internally. This can only occur whenthe wave in a medium with a higher refractive index reaches a boundarywith a medium of lower refractive index. For example, it will occur withlight reaching air from plastic, but not when reaching plastic from air.

In the context of the present application, the term “reflector” and“light reflector” do not encompass a total internal reflection opticalsurface, but instead include polished surfaces, mirrors, metals and thelike that reflect light regardless of the incident angle.

Like the implementation of FIG. 14A, in the implementation of FIG. 20Athe proximal connector 304 may be made of a plastic material. Generally,plastics have an index of refraction of between about 1.4 to about 1.6as compared to air that has an index of refraction of 1.0. In theimplementation of FIG. 20A there are first, second, third and fourthoptical surfaces 374-377 used to direct light from the end emittingfiber 302 to a target location inside the infusion shaft 300. The secondand third optical surfaces 375 and 376 are each bounded on one side bythe plastic material that forms the proximal connector 304 and on theother side by air. In regard to the second optical surface 375, a cavity378 that is partially defined by the second optical surface is providedin a side of the proximal connector and filled with air. In addition,the angle of inclination of each of the optical surfaces 375 and 376 ischosen so that the incident angle at which light impinges on thesurfaces is greater than the critical angle, the critical angle beingthe inverse sine of the ratio of the index of refraction of air over theindex of refraction of the plastic that forms the proximal connector.With the index of refraction of plastics ranging between about 1.4 toabout 1.7, according to some implementations the critical angle isgreater than about 36 degrees to greater than about 46 degrees dependingon the specific index of refraction of the plastic that is used in theconstruction of the proximal connector.

With reference to FIG. 20B, the path traveled by the light emitted bythe end emitting fiber is shown. Like the implementation of FIG. 14A, agap may exist between the end of fiber 302 and the end wall of the endemitting fiber lumen 310. In any event, the end wall 362 a of lumen 362constitutes the first optical surface 374 through which the lightemitted by the fiber 302 passes. The gap may be filled with an indexmatching gel or adhesive that has an index of refraction between that ofthe core of fiber 302 and that of the plastic that forms the proximalconnector 304. The light path 379 between the end of the fiber 302 andits target location involves a passing of the light through the firstand fourth optical surface 374 and 377 and a total internal reflectionon each of optical surfaces 375 and 376 as shown in FIG. 20B. In thecontext of the implementation of FIGS. 20A and 20B, each of opticalsurfaces 374 and 377 is a refractive optical surface and each of opticalsurfaces 375 and 376 is a total internal reflection optical surface.

As explained above, a cavity 378 filled with air is formed in a side ofthe proximal connector 304. According to some implementations the cavityis open to the environment as shown in FIGS. 20A and 20B, whereas inother implementations the cavity 378 is closed to prevent anycontaminates from entering the cavity after the cavity has been filledwith purified air. According to some implementations closure of thecavity 378 is achieved by wrapping the outer surface of the proximalconnector 304 with a heat shrink and then heat shrinking it tightlyabout the outer surface. According to some implementations, the heatshrink wrapping has light reflective properties that act to containdisinfecting light inside the proximal connector in a manner like thatdescribed above.

The formation of the optical surfaces internal to the proximal connector304 can be difficult. This is because pins with ends having opticalquality finishes are used in the formation of the optical surfacesduring a molding process. During the molding process the end of the pinsare strategically located so that the molten plastic forms over the endsof the pins. Because the end of the pins have an optical quality finish,the plastic surfaces formed by the pins will also have an opticalquality finish when the plastic solidifies.

A problem associated with this method of forming the optical surfaces isthat the desired location of the ends of the pins is not always easilyaccessible, and at times is not accessible at all. The implementation ofFIGS. 21A and 21B addresses this issue with the use of an insert 380that is manufactured separately from the proximal connector 304. Asshown in the figures, the insert 380 is affixed inside a cavity 381located in a side of the proximal connector 304. The system includesfirst, second, third and fourth optical surfaces 382-385, of which thefirst, second and third optical surfaces 382-384 are located in or onthe insert 380 and total internal reflection occurs at the second andthird optical surfaces 383 and 384. The end of the end emitting fiber302 is located inside a lumen 388 of the insert 380, and according tosome implementations the insert 380 is constructed of the same materialthat forms the proximal connector 304. The end wall of the insert lumen388 constitutes the first optical surface 382 through which light passestoward the second optical surface 383. Optical surfaces 383 and 384 areeach bounded on one side by the plastic material that forms the insert380 and on the other side by air 386. In addition, the angle ofinclination of each of the optical surfaces 383 and 384 is selected sothat the incident angle at which the light impinges on these surfaces isgreater than the critical angle, which in this case is the inverse sineof the ratio of the index of refraction of air over the index ofrefraction of the plastic that forms the insert 380.

With reference to FIG. 21B, the path 388 traveled by the light emittedby the end emitting fiber 302 is shown. Like the implementations ofFIGS. 14A and 20A, a gap may or may not exist between the end of fiber302 and the end wall of the insert lumen 388. When a gap is provided itmay be filled with an index matching gel or adhesive that has an indexof refraction between that of the fiber core and that of the materialthat forms the proximal connector 304. The light path 389 between theend of the fiber 302 and its target location involves a passing of thelight through the first and fourth optical surface 382 and 385 and atotal internal reflection on each of optical surfaces 383 and 384 asshown in FIG. 21B. As shown in FIGS. 21A and 21B, the insert 380 residesinside a cavity 381 formed in the side of the proximal connector 304.The shapes of the insert 380 and cavity 381 are selected so that airgaps 386 exists at the boundary of each of the second optical surface383 and third optical surface 384. According to some implementations thecavity381 is open to the environment as shown in FIGS. 21A and 21B,whereas in other implementations the cavity 381 is closed to prevent anycontaminates from entering the cavity after the cavity has been filledwith purified air.

In the context of the implementation of FIGS. 20A and 20B, each ofoptical surfaces 382 and 385 is a refractive optical surface and each ofoptical surfaces 383 and 384 is a total internal reflection opticalsurface.

In the exemplary implementation of FIG. 3 there exits eight opticalfibers. These include the radially emitting fiber 205 and imaging fiber207 of the main shaft 200 and also the radially emitting fibers 301 andend emitting fibers 302 associated with each of the three infusionshafts 300. As noted above, there may be fewer or more than threeinfusion shafts 300. In addition, according to some implementations oneor more of the infusion shafts 300 may possess only one of a radiallyemitting fiber 301 and an end emitting fiber 302 as exemplified above inthe description of FIGS. 19A and 19B. Further, according to someimplementations the main shaft 200 may include only one of adisinfecting radially emitting fiber 205 and an imaging fiber 207.Moreover, one or more of the main shaft 200 and infusion shafts 300 maynot be provided with any type of optical fiber. As such, it is evidentthat any of a variety of implementations contemplated herein may includeany combination of fewer or more than eight optical fibers. With this inmind, the forthcoming description is directed to the implementation ofFIG. 3.

Light may be delivered to the various optical fibers residing in themain shaft 200 and infusion shafts 300 in a number of ways. For example,the disinfecting radially emitting fibers 205 and 301 may each beoptically coupled to a common first laser, the disinfecting end emittingfibers 302 may each be optically coupled to a common second laser, andthe imaging fiber 207 may be optically coupled to a third laser as shownin FIG. 22C. In this manner, the type of light delivered to each of thethree types of fibers may be tailored to its intended function. Thetypes of light may be distinguished, for example, by their wavelengthand optical power. However, according to some implementations all of theoptical fibers may be optically coupled to a single common laser asshown in FIG. 22A, while in other implementations each optical fiber isoptically coupled to its own individual laser as shown in FIG. 22B. Inthis latter case the type of light delivered to each of the opticalfibers may be individually tailored to its intended function like thatdiscussed above in the implementation of FIG. 22C.

In the description that follows light is routed to the optical fibersresiding in the main shaft 200 and infusion shafts 300 via the CVC hub400. However, in other implementations one or more or all of the opticalfibers enter their respective lumens inside the main shaft and infusionshaft without having passed through the hub 400. An advantage of runningthe optical fibers through the hub 400 as shown in FIG. 3 is that, otherthan the umbilical cord 500, there are no other optical fibers residingoutside the CVC 100 to interfere with a health care clinician's accessto the various components of the CVC. As such, existing CVC clinicalpractices may be followed with little or no change.

FIG. 23 is a top view of an optical fiber umbilical cord 500 that isconnectable to the hub 400 of the CVC 100. FIG. 24A is a perspectiveview of an end of the umbilical cord 500. FIG. 24B is an end view of thedistal end of the umbilical cord. The umbilical cord 500 is configuredto transport light that originates from a one or more lasers to each ofthe optical fibers residing in the main shaft 200 and infusion shafts300 of the CVC 100. The umbilical cord 500 originates at a proximaloptical connector 501 that has eight ports that receive and direct lightto eight transport fibers 503 that run the length of the cord 500 withall but three of the transport fibers terminating at a location justdistal to a hub connector 502. The hub connector 502 facilitates aphysical connection of the distal end portion of the cord 500 to the hub400 which will be discussed in more detail below. In the implementationof FIGS. 23 and 24A-B, the transport fibers 503 located inside the cord500 comprise outer jackets and are disposed within the lumen of anelastomeric sheath. According to some implementations the fibers arelocated in Kevlar strength members located inside the sheath 504. Thesheath 504 originates at the distal end of connector 501 and terminatesat or just distal to the hub connector 502.

In the implementation of FIG. 3, five of the optical fibers that residein the main shaft 200 and infusion shafts 300 are radially emittingfibers. These are fibers 205 and 207 of the main shaft 200 and fiber 301in each of the three infusion shafts 300. The remaining three opticalfibers are the end emitting fibers 302 residing in the three infusionshafts 300.

Distal to the hub connector 502 each of the transport fibers 503 isdevoid of an outer jacket.

Five of the transport fibers 503 terminate a short distance distal tothe hub connector 502 and are subsequently physically and opticallycoupled to respective radially emitting fibers 205 and 207 of the mainshaft 200 and radially emitting fibers 301 of the three infusion shafts300 by the use of fiber optic couplers 505. In the implementation ofFIGS. 23 and 24A-B the end emitting fibers 302 of the infusion shafts300 are contiguous with the transport fibers 503, but without the outerjacket. As will be explained in detail below, fibers 205, 207, 301 and302 are routed to their respective lumens 204, 206, 309 and 310 insidethe main shaft 200 and infusion shafts 300 via channels located in thehub 400.

As shown in the figures, according to some implementations, all or amajority of the fibers 205, 207, 301 and 302 extending from theumbilical 500 into the hub 400 are devoid of a jacket and comprise onlya core/cladding in the radial emitting case and a core/cladding/bufferin the end emitting case. This arrangement significantly reduces theprofile of the optical fibers and also the profile of the componentsinto which they are incorporated.

Proximal and distal strain reliefs 506 and 507 are respectively providedat the junction of the connector 501 with sheath 504 and at the junctionof the hub connector 502 with sheath 504 to guard against the transportfibers 503 from breaking inside the umbilical cord at these junctions.In conjunction with or in lieu of providing strain reliefs, the sheath504 may be structured and/or made of a material that prevents the sheathfrom bending beyond a minimum bending radius of one or more of thetransport fibers 503. The material may be, for example, a high durometerelastomer and/or a reinforced elastomer embedded with one or morestiffening elements (e.g. a coil, mandrel, braiding, Kevlar strengthmembers etc.).

FIG. 22A illustrates an implementation of a laser system 520 that isconfigured to deliver light from a single laser 521 to the proximaloptical connector 501 of the fiber optic umbilical cord 500. The systemincludes a controller 522 that is connected to a user interface 523. Thesystem includes a laser driver 524 under the control of the controller522. In response to instructions received from the controller 522, thedriver 524 controls the operation of the laser 521. A user interface523, such as a keypad or touchscreen, may be provided to communicate tothe controller 522 user input instructions. The user input instructionsmay cause the controller 522 and driver 524 to operate the laser 521 ina user desired manner. For example, the user input instructions may beused to alter the wavelength and/or optical power of the light emittedby the laser 521. According to some implementations the power leveldelivered to an optical fiber is regulated to provide a dose ofdisinfecting light that both kills bacteria and generates an amount ofheat that does not result in patient discomfort (e.g. maintaining theCVC components that contact the patient below 104° F.). According tosome implementations the power level of the light delivered ismaintained constant whilst the power is turned on and off to provide thedesired dose of disinfecting light. According to some implementationsthe optical power level of the light emitted from laser 521 issufficient to deliver a desired dose like those discussed above. Patientcomfort is maintained by ensuring the maximum irradiance impingent uponthe skin is less than 200 mW/cm².

Light emitted by the laser 521 is transported by an optical fiber 525(e.g. multimode fiber) to a beam splitter 526 that splits the laser beamemitted by the laser 521 into eight separate laser beams. The eightlaser beams are individually transported via optical fibers 527 (e.g.multimode fibers) to a breakout box 528 that is configured to directeach of the eight laser beams into eight separate ports of an opticalconnector 529. The optical connector 529 is in turn connected to aproximal connector 531 of an eight channel patch cord 530 that possesseseight transport fibers (e.g. multimode fibers). The transport fibers ofthe patch cord 530 deliver the eight laser beams to the proximal opticalconnector 501 of the fiber optic umbilical cord 500 via a distalconnector 532.

According to some implementations the optical power of each of the laserbeams transported by optical fibers 527 is sufficient to deliver adesired dose like those discussed above. In instances when light is tobe delivered to both radially emitting fibers and end emitting fibers,each of the radially emitting fibers receive a larger proportion of theoptical power than each of the end emitting fibers.

According to some implementations two or more lasers (e.g. three lasers)may be combined to generate a common laser beam that passes throughoptical fiber 525.

According to each of the laser systems disclosed herein, when light isto be delivered to an imaging fiber, the laser system may possess aseparate laser dedicated to delivering light only to the imaging fiberas in laser system 550 of FIG. 22C.

FIG. 22B illustrates an implementation of a laser system 540 that isconfigured to deliver light from eight individual lasers 542 a-h to theproximal optical connector 501 of the fiber optic umbilical cord 500.The system includes a controller 522 that is connected to a userinterface 523. The system includes an eight channel laser driver 541that is under the control of the controller 522. In response toinstructions received from the controller 522 the eight channel driver541 individually controls the operation of the lasers 542 a-h. A userinterface 523, such as a keypad or touchscreen, may be provided tocommunicate to the controller 522 user input instructions. The userinput instructions may cause the controller 522 and eight channel driver541 to operate the laser 521 in a user desired manner. For example, theuser input instructions may be used to separately alter the wavelengthand/or optical power of the light emitted by the lasers 542 a-h, or toturn the lasers on and off. The ability to separately control the lasersallows them to be activated at different times and/or with differentpower levels in a way that optimizes the efficacy of the disinfectingprocess and/or control the amount of heat generated in the CVC toprevent patient discomfort. To this end, different parts of the CVC maybe disinfected at different times and/or at different power levels.According to some implementations the delivery of disinfecting light toan optical fiber is triggered by an event. For example, one or morecomponents of the CVC may be equipped with a motion or temperaturesensor that detects when a part of the CVC has been moved or touched.According to such implementations the sensor may communicate with thecontroller 522 to cause one or more of the lasers to be activated uponthe occurrence of an event.

Light emitted by the lasers 542 a-h is transported by optical fibers 544(e.g. multimode fibers) to a breakout box 545 that is configured todirect each of the eight laser beams into eight separate ports of anoptical connector 546. The optical connector 546 is in turn connected toa proximal connector 531 of an eight channel patch cord 530 thatpossesses eight transport fibers (e.g. multimode fibers). The transportfibers of the patch cord 530 deliver the eight laser beams to theproximal optical connector 501 of the fiber optic umbilical cord 500 viaa distal connector 532.

FIG. 22C illustrates an implementation of a laser system 550 that isconfigured to deliver light from three lasers 552 a-c to the proximaloptical connector 501 of the fiber optic umbilical cord 500. The systemincludes a controller 522 that is connected to a user interface 523. Thesystem includes a three channel laser driver 551 under the control ofthe controller 522. In response to instructions received from thecontroller 522 the driver 551 controls the operation of the three lasers552 a-c. A user interface 523, such as a keypad or touchscreen, may beprovided to communicate to the controller 522 user input instructions.The user input instructions may cause the controller 522 and driver 551to individually operate the lasers 552 a-c in a user desired manner. Forexample, the user input instructions may be used to individually alterthe wavelength and/or optical power of the light emitted by each of thelasers 552 a-c, or to turn the lasers on and off. As stated above, theability to separately control the lasers allows them to be activated atdifferent times and/or with different power levels in a way thatoptimizes the efficacy of the disinfecting process and/or control theamount of heat generated in the CVC to prevent patient discomfort.

Light emitted by the laser 552 a is transported by an optical fiber 556a (e.g. multimode fiber) to a beam splitter 553 a that splits the laserbeam emitted by the laser 552 a into four separate laser beams to beassociated with the disinfecting radially emitting fiber 205 of the mainshaft 200 and the disinfecting radially emitting fibers 301 of the threeinfusion shafts 300. The four laser beams are individually transportedvia optical fibers 557 a (e.g. multimode fibers) to a breakout box 554that is configured to direct each of the four laser beams into fourseparate ports of an optical connector 555. Light emitted by the laser552 b is transported by an optical fiber 556 b (e.g. multimode fiber) toa beam splitter 553 b that splits the laser beam emitted by the laser552 b into three separate laser beams to be associated with thedisinfecting end emitting fibers 302 of the three infusion shafts 300.The three laser beams are individually transported via optical fibers557 b (e.g. multimode fibers) to a breakout box 554 that is configuredto direct each of the three laser beams into three separate ports of theoptical connector 555. Light emitted by laser 552 c, that is to beassociated with the imaging fiber 207 of the main shaft 200, istransported by an optical fiber 556 c (e.g. a multimode fiber) directlyto the breakout box 554 which is configured to direct the laser beaminto a port of the optical connector 555. The optical connector 555 isin turn connected to a proximal connector 531 of an eight channel patchcord 530 that possesses eight transport fibers (e.g. multimode fibers).The transport fibers of the patch cord 530 deliver the eight laser beamsto the proximal optical connector 501 of the fiber optic umbilical cord500 via a distal connector 532.

According to some implementations each of lasers 522 a and 522 bcomprise blue lasers and laser 552 c is a red laser.

FIG. 25 shows a top perspective view of the various parts that from thehub 400 according to one implementation. The parts include a bottom tray401, a mid-tray 402, a cover 403 and a top gasket 404, of which enlargedperspective views are respectively provided in FIGS. 26-29. The bottomtray 401 and mid-tray 402 include features for supporting the proximalend of the main shaft 200 and the distal ends of the infusion shafts 300relative to one so that the working lumens 308 of the infusion shaftsand the working lumens 201 a-c of the main shaft may be connected withthe use of conduits located inside the hub 400. The bottom tray 401 andmid-tray 402 also include features that define one or more channels forstrategically routing the optical fibers through the hub 400 in a mannerthat protects the optical fibers against breakage. The channels thatpossess the radially emitting fibers may also run above, below or to theside of the conduits inside the hub that join the working lumens 308 ofeach of the infusion shafts 300 to the working lumens 201 a, 201 b and201 c of the main shaft 200. The fiber channels may be formed by any ofa variety of structures including, but not limited to, continuous wallsegments, spaced-apart posts, etc. In channels that have one or morebends along their length, to protect against breakage of the opticalfibers, the bends are constructed to prevent a bending of the opticalfiber housed therein beyond its minimum bending radius. For example,each of the one or more bends may have a radius of curvature that isequal to or greater than the minimum bending radius of the opticalfiber.

As shown in FIG. 26, according to some implementations the bottom tray401 has a plurality of channels formed therein. Each of channels 405 a-cis configured to hold one of the infusion shafts 300. The depth andwidth dimensions of the channels 405 a-c may respectively correspond tothe length and width dimensions of the infusion shaft key portions 311.A receptacle 406 in the bottom tray 401 is configured to accept the hubconnector 502 of the optical fiber umbilical 500 in a manner that locksthe proximal connector onto the bottom tray. Distal to the receptacle406 is an elongate channel 407 that guides the optical fibers thatemanate from the umbilical 500 into the hub 400. Distal to channel 407there resides a raised platform 408 that includes a top surface 408 aand a curved wall portion 408 b. (It is important to note that the topsurface 408 a need not be a planar/level surface) A channel 409, whichis at least partially formed by the curved wall portion 408 b of theraised platform 408, communicates fiber channel 407 to fiber channels410 a-c. Each of fiber channels 410 a-c is respectively located distalto channels 405 a-c and assists in guiding the radially emitting fiber301 and/or end emitting fiber 302 into their respective lumens 309 and310 inside the key portions 311 of the infusion shafts 300.

FIG. 30 illustrates a perspective view of a partially assembled hubaccording to one implementation with the mid-tray 402 being attached tothe bottom tray 401. A distal end 390 a-c of each of the infusion shafts300 extends distally from the mid-tray 402. In the implementation ofFIG. 30 there exist eight optical fibers consistent with the embodimentof FIG. 3 described above. According to the implementation of FIG. 30all of the fibers 205, 207, 301 and 302 extend through fiber channels407 and 409 before they branch apart. Six of the fibers (that is fibers301 and 302 for each of the three infusion shafts 300) pass to theinfusion shafts 300 via fiber channels 410 a-c while two of the fibers(that is fibers 205 and 207 of the main shaft 200) pass to the mainshaft 200 via a fiber channels 412 and 413. As shown in FIG. 30, thevarious fiber channels may be disposed at different elevations withinthe hub 400. This provides greater flexibility in laying out the opticalfiber pathways.

FIGS. 27A and 27B respectively show top and bottom perspective views ofthe mid-tray 402 according to one implementation. The mid-tray includesgrooves 413 a-c and 414 that each extend between its proximal and distalends 418 and 419, respectively. As shown in FIG. 30, when the infusionshafts 300 are assembled on the bottom tray 401 and in the mid-tray 402the distal end portion 390 a-c of each of the infusion shafts protrudesdistal to the distal side 419 of the mid-tray. According to someimplementations the portions of the tubular body 303 of each of theinfusion shafts that form the working lumens 308 (e.g. semi-circularregion of the infusion shaft) fit tightly within their respectivegrooves 413 a-c. In some instances the fit between the infusion shafts300 and the grooves 413 a-c produces a liquid-tight seal at theirinterface along at least a portion of the length of the grooves 413 a-c.According to some implementations the mid-tray 402 also includes areceptacle 417 that houses at least a portion of the hub connector 502of the optical fiber umbilical 500.

During an assembly of the hub 400 a portion of the main shaft 200 may besupported on a cradle 411 positioned atop the raised platform 408.According to some implementations the cradle 411 has a grooved externalsurface 411 a that conforms to the external surface of the main shaft.When positioned on the cradle 411, as shown in FIG. 30, the elongateproximal end portion 220 of the main shaft 200 extends into the curvedchannel 413 of the mid-tray 402 where fibers 205 and 207 enter theproximal end 221 of the elongate proximal end portion 220.

Assembly of the CVC 100 may occur in any of a variety of steps to whichthe following assembly method represents only but one example. At stepone the hub connector 502 of the fiber optic umbilical cord 500 is fixedinside the receptacle 406 of the bottom tray 401. The radially emittingfibers 301 and end emitting fibers 302 associated with the infusionshafts 300 are then placed inside the lumens 309 and 310 of theirrespective infusion shafts. This step may include fixing the distal endof the end emitting fibers 302 inside the proximal connectors 304 of theinfusion shafts 300 with, for example, an index matching adhesive asdiscussed above. With the fibers 301 and 302 properly positioned insidetheir respective lumens inside the infusion shafts 300, the distal endportion of each of the infusion shafts is positioned on the bottom tray401. According to some implementations this includes aligning each ofthe distal end portions of infusion shafts with channels 405 a-c in thebottom tray 401 with each of their key portions 311 respectivelyresiding in one of said channels. The key portions 311 may bepressed-fit into the channels 405 a-c and/or secured inside saidchannels with the use of an adhesive.

With the proximal end portions of the infusion shafts 300 in place onthe bottom tray 401 the six fibers 301 and 302 are routed through thebottom tray fiber channels 407, 409 and 410 a-c.

With the infusion shafts 300 and fibers 301 and 302 in place, themid-tray 402 is positioned over and attached to a proximal end portionof the bottom tray 401. When the mid-tray 402 is attached to the bottomtray 401 the distal end portions of the infusion shafts reside insidetheir respective grooves 413 a-c inside the mid-tray 402 as depicted inFIG. 30. After the mid-tray 402 is positioned on the bottom tray 401,the radially emitting fiber 205 and imaging fiber 207 are routed throughfiber channels 407, 409, 412 and 413 and into their respective lumens204 and 206 in the main shaft 200.

As discussed above, according to some implementations one or more or allof the curves of the structures that form the fiber channels (e.g.channels 407, 409, 410 a-c and 413) are endowed with a radius ofcurvature that is no less than the minimum bending radius of one or moreof the fibers that pass through them.

Because a later step involves a casting of a urethane or other polymericmaterial to encapsulate the hub, with the infusion shafts and opticalfibers in place the cover 403 is situated to reside above the fiberchannels 407, 409, 410 a-c, 412 and 415 formed in the bottom tray 401and mid-tray 402 as shown in FIG. 31. The cover 403 serves to isolatethe optical fibers from the casting material so that the optical fibersmaintain a freedom of movement inside the hub when the casting iscomplete. The cover 403 includes an opening 441 through which the cradle411 of the bottom tray protrudes. The cover 403 also includes opening442 a-c through which the distal ends 390 a-c of the infusion shafts 300respectively protrude.

With the cover 403 in place to protect the optical fibers as shown inFIG. 31, the main shaft 200 is positioned on the cradle 411 atop theraised platform 408 with at least a portion of the length of itselongate proximal end portion 220 placed inside the fiber channel 413.According to some implementations the main shaft 200 is positioned onthe cradle 411 so that the proximal opening of the working lumen 201 aresides proximal to the raised platform 408 as shown in FIG. 30.Positioning the proximal end of the working lumen 201 a of the mainshaft proximal to the raised platform 408 advantageously shortens thepath taken to couple the working lumens 308 of the infusion shafts tothe infusion shafts 201 a-c of the main shaft 200. This positioning alsofacilitates a routing of at least a portion of the length of theconduits that interconnect the infusion shafts to the main shaft abovethe fiber channels 410 a-c so that these lengths of the conduits may beirradiated with bacterial disinfecting light emitted by the radiallyemitting fibers 301 that reside in fiber channels 410 a-c.

As shown in FIG. 30, one or more or all of the fibers 205, 207, 301 and302 is routed in the hub 400 so as not to be taut along at least aportion of the structures that form the fiber channels located in thebottom tray 401. This provision of slack in the one or more opticalfibers inside the hub guards against excessive tensile forces beingapplied to the fibers when the main shaft 200 and infusion shafts 300are bent or pulled in tension as a result of the slack being taken upinside the hub when the shafts are bent. This is particularly importantwhere at least a portion of the optical fiber is longitudinally fixedinside the main shaft or infusion shaft, like with certainimplementations of the imaging shaft 205 and end emitting fibers 302discussed above.

With the cover 403 in place, the top gasket 404 is placed atop theperiphery of the cover 403 to hold the cover in place prior to thecasting step. The gasket 404 includes at its distal end a groove 445through which the main shaft 200 passes. As shown in FIGS. 25-31, holesand posts located about the periphery of the bottom tray 401, mid-tray402, cover 403 and top gasket 404 facilitate an aligning and coupling ofthe components prior to the casting step.

As discussed above, conduits are used to fluidly connect the workinglumens 308 of the infusion shafts to the respective working lumens 201a-c of the main shaft 200. According to some implementations theconduits are formed during the casting process mentioned above.According to such implementations when the hub is in a partiallyassembled state as shown in FIG. 31, an elongate flexiblebeading/mandrel 450 (see FIG. 32) is inserted through each of theworking lumens 308 of the infusion shafts 300 and into the respectiveworking lumens 201 a-c of the main shaft 200. With the beadings in placethe entirety of the assembly is cast with a polymeric material, such asa urethane. The casting is performed so that the casting materialtotally encapsulates those portions of the beadings 250 that extendbetween the distal end of the infusion shafts and proximal end of themain shaft. Upon the casting material having cured, the beadings 450 areremoved so that flow channels encapsulated inside the casting existbetween the working lumens of the infusion shafts 300 and main shaft200. FIG. 3 shows the external surface of the hub 400 when the castingstep is complete.

According to other implementations, as shown in FIG. 33, the conduits460 a-c that connect the working lumens of the infusion shafts and mainshaft are not cast, but are instead physically and fluidly coupled totheir respective working lumens before the casting step. According tosuch implementations the conduits 460 a-c may be fluidly sealed to theworking lumens of the infusion shafts and main shaft prior to thecasting process. According to other implementations the interfacesbetween the conduits 460 a-c and the working lumens of the infusionshafts and main shaft are sealed with the casting material during thecasting process.

According to some implementations the casting material and the cover 403of the hub 400 each comprises a material that is transparent ortranslucent to the light emitted by the disinfecting radially emittingfibers 205 and 301. According to other implementations the castingmaterial, mid-tray 402 and cover 403 of the hub 400 each comprises amaterial that is transparent or translucent to the light emitted by thedisinfecting radially emitting fibers 205 and 301. According to yetother implementations the casting material, bottom tray 401, mid-tray402 and cover 403 of the hub 400 each comprises a material that istransparent or translucent to the light emitted by the disinfectingradially emitting fibers 205 and 301. By virtue of their transparency ortranslucence, these components of the hub enable light emitted by thelight disinfecting radially emitting fibers to disinfect not only theinfusion shaft 300 and main shaft 200 lumens, but to also internallyflood the hub with bacterial disinfecting light to also effectuate adisinfecting of the hub itself, including its outer surfaces.

As shown in FIG. 34, according to some implementations light reflectors453 and 454 may be affixed to the top and bottom surfaces 451 and 452 ofthe hub 400 in order to minimize the loss of disinfecting light out ofthe hub. A trapping of the bacterial disinfecting light inside the hubenhances the light exposure on the internal components of the hub. Thisincreases the bacteria killing effectiveness of the disinfecting lightemitted into the hub. It also reduces the amount of time and/or thepower needed to effectuate a disinfecting of the hub. According to otherimplementations, the casting material used to cast the hub may beimpregnated with light reflecting elements that act to direct light intothe hub. According to other implementations the casted hub 400 iswrapped with a material that has an internal light reflective surface.According to one implementation the material comprises shrink wrap thatis shrunk about the external surfaces of the hub. According to yet otherimplementations, one or more of the fiber channels located in the bottomtray 401 have surfaces that are coated with a light reflective material,such as, for example, a light reflective paint.

According to some implementations disinfecting light is delivered intothe CVC only by way of use of end emitting fibers. Thus, unlike theimplementation of FIG. 30, each of the infusion shafts 300 and mainshaft 200 of the implementation of FIGS. 35A-38 is devoid of a radiallyemitting fiber and a radially emitting fiber lumen.

In the implementation of FIGS. 35A-38 the disinfecting light isdelivered into each of the infusion shafts 300 at two locations. Thefirst location is in the proximal connector 304 of the infusion shaft300 in which disinfecting light is delivered in a manner consistent withwhat has been described above with one or more optical surfaces and/orone or more light reflectors of the proximal connector being used todisperse disinfecting light emitted from an end emitting fiber 302 intoat least a portion of the infusion shaft 300. The second location isinside the working lumen 308 of the infusion shaft 300 near its distalend. This second location is located inside the hub 400.

Although not shown in the figures, the CVC of FIGS. 35A-38 may alsoinclude an imaging fiber 207 that runs along a length of the main shaft200 as previously described.

In the implementation depicted in FIGS. 35A and 36 there are six opticalfibers that extend from the fiber optic umbilical 500 into the hub 400.The six optical fibers are comprised of three end emitting fibers 302that deliver light to the proximal connectors 304 of the infusion shaftsand three end emitting fibers 337 a-c that deliver light into theworking lumens 308 of the infusions shafts inside the hub. The mainshaft 200 and infusion shafts 300 are supported in the hub 400 in amanner consistent with that described above in conjunction with theimplementation of FIG. 30.

FIG. 35B shows the hub of FIG. 35A without the optical fibers 302 and337 a-c to better identify the fiber channels 407, 409, 410 a-c, 412,416, 420, 422, 423 a-b and 427 running through the hub 400. Withreference to each of FIGS. 35A and 36, the end emitting fibers 302 thatextend into the proximal connectors 304 of the infusion shafts 300 passthrough the bottom tray 401 of the hub via fiber channels 407, 409 and arespective one of channels 410 a-c. End emitting fiber 337 a passes fromthe fiber optic umbilical 500 and into the fiber channel 423 a in themid-tray 402 via fiber channels 407, 409, 427, and 422. Each of endemitting fiber 337 b and 337 c passes from the fiber optic umbilical 500and into its respective fiber channel 423 b and 423 c in the mid-tray402 via fiber channels 407, 409 and 420. In the implementation of FIGS.35A and 36 at least a portion of each of the end emitting fibers 337 a,337 b, 337 c overlaps with another one of the end emitting fibers 337 a,337 b, 337 c in one or both of the bottom tray 401 and mid-tray 402.

FIG. 38 shows a cross-section view of the hub 400 with a first of theinfusion shafts 300 secured between the bottom tray 401 and mid-tray402. The end of the end emitting fiber 337 a rests inside channel 423 afacing an optical surface 426 a formed on an inner surface of themid-tray 402. In the implementation of FIG. 38, the end emitting fiber337 a is optically coupled with the optical surface 426 a by use of anindex matching gel or adhesive 428. According to one implementation anindex matching adhesive is used to both secure the fiber 337 a insidethe downward sloping channel 423 a and to optically couple the endemitting fiber to the optical surface 426 a. A recess 424 a inside themid-tray 402 is positioned to reside over an opening 331 cut into thetubular body 303 of the infusion shaft 300. The arrangement of the endemitting fiber 337 a, optical surface 426 a, recess 424 a and opening331 results in bacterial disinfecting light 339 being transmitted fromthe end emitting fiber into the working lumen 308 of the infusion shaft300 when disinfecting light is transmitted through the end emittingfiber. At least that portion of the mid-tray that resides between thedistal end of optical fiber 337 a and recess 424 a is made of a materialthat is transparent or translucent to the disinfecting light 339.According to some implementations the entirety of the mid-tray 402 ismade of a material that is transparent or translucent to thedisinfecting light 339.

End emitting fibers 337 b and 337 c may be arranged similar to fiber 337a to effectuate a disinfecting of at least a portion of the workinglumens 306 of the other infusion shafts 300.

Like with the implementation of FIG. 30, one or more or all of thefibers 302 and 337 a-c is routed in the hub 400 so as not to be tautalong at least a portion of the structures that form the fiber channelslocated in the bottom tray 401. This provision of slack in the one ormore optical fibers guards against excessive tensile forces beingapplied to the fibers when the infusion shafts 300 are bent. This isparticularly important where at least a portion of the optical fiber islongitudinally fixed inside infusion shaft, like with certainimplementations of the end emitting fibers 302 discussed above.

Fluidly connecting the working lumens 308 of the infusion shafts 300 tothe working lumens 201 a-c of the main shaft 200 may be accomplished ina manner similar to that described above in conjunction with theimplementation of FIG. 30. Like with the implementation of FIG. 30, whenthe casting process is complete, the entirety of the hub 400 may beencapsulated by the casting material and assume an appearance like thatshown in FIG. 3.

To protect against breaking the end emitting fibers, the bends of thefiber channels that contain them are constructed to prevent a bending ofthe optical fibers beyond their minimum bending radius. For example, oneor more or all of the bends may have a radius of curvature that is equalto or greater than the minimum bending radius of the optical fiber.Also, as shown in FIG. 36, the path of the optical fibers about theraised platform 408 may be selected to ensure that the optical fibers donot bend beyond their minimum bending radius. For this purpose some ofthe optical fibers may travel in a clockwise direction about the raisedplatform 408, while others travel in a counter-clockwise direction aboutthe raised platform. In the Implementation of FIGS. 35A-38 all the endemitting optical fibers travel in a clockwise direction about the raisedplatform 408 (as viewed from above the bottom tray 401) except fiber 337a that travels in a counter-clockwise direction about the raisedplatform. The provision of alternate pathways for the optical fibers totravel around the raised platform 408 increases design freedom,particularly in the layout of the bottom tray 410 and mid-tray 402 fiberchannels. The provision of alternate pathways can also facilitate asmaller hub design to provide it with a footprint that is morecomparable to the foot print of a traditional CVC hub. As discussedabove, by maintaining the disinfecting CVC design similar to traditionalCVC designs established clinical practices may be followed.

Light reflectors may be incorporated into, attached to or coated on thehub 400 in a manner consistent with that described above in conjunctionwith the implementation of FIG. 30.

FIG. 39A illustrates a partially constructed hub 400 of a CVC accordingto another implementation. Like with the previously describedimplementations, the hub is configured to fluidly connect the workinglumens 308 of the infusion shafts 300 to the working lumens 201 a-c ofthe main shaft 200. The conduits that connect the working lumens may belike those discussed above in conjunction with the implementation ofFIG. 30.

According to some implementations disinfecting light is delivered intothe CVC only by way of use of end emitting fibers. As a result,according to some implementations each of the infusion shafts 300 andmain shaft 200 is devoid of a radially emitting fiber and a radiallyemitting fiber lumen.

In the implementation of FIG. 39A the disinfecting light is deliveredinto one or more of the proximal connectors 304 of the infusion shafts300 in a manner consistent with what has been described above with oneor more optical surfaces and/or one or more light reflectors of theproximal connector being used to disperse disinfecting light emittedfrom an end emitting fiber 302 into at least a portion of the infusionshaft. Disinfecting light is also delivered out the ends 358 of otherend emitting fibers 338 a-c to flood at least that region of the hubthat contains the conduits connecting the working lumens of the infusionshafts 300 and main shaft 200.

According to some implementations the ends of end emitting fibers 338a-c comprise end caps 358 that are optically coupled to the cores of theend emitting fibers. When the hub is fully constructed the ends of theend emitting fibers 336 a-c will reside in the casting material thatenvelops the hub. The use of the end caps 358 provides at least twoadvantages. The advantage is that by lowering the power density of thelight that exits the fibers the light will be below the damage thresholdof the casting material.

As shown in FIG. 39D, according to some implementations support fixtures364 a-c are provided at or near the distal end of channels 421 a-c toassist in respectively fixing the ends of the end emitting fibers 338a-c on the hub. As illustrated in FIGS. 39A and 39C, according to someimplementations the core and cladding portion of the end emitting fibers338 a-c are clamped inside the support fixtures 364 a-c with the endcaps 358 being positioned to protrude from the face 402 a of themid-tray 402. According to other implementations the end caps 358 areinstead held fixing inside the support fixtures 364 a-c.

Although not shown, the CVC of FIG. 39A may also include an imagingfiber 207 that runs along a length of the main shaft 200 as describedabove.

In the implementation depicted in FIG. 39A there are six optical fibersthat extend from the fiber optic umbilical 500 into the hub 400. The sixoptical fibers are comprised of three end emitting fibers 302 thatdeliver light to the proximal connectors 304 of the infusion shafts 300and three end emitting fibers 338 a-c that deliver light into the regionof the hub that contains the conduits connecting the aforesaid workinglumens of the infusion shafts 300 and main shaft 200. The main shaft 200and infusion shafts 300 are supported in the hub 400 in a mannerconsistent with that described above in conjunction with theimplementation of FIG. 30.

FIG. 39B shows the hub of FIG. 39A without the optical fibers 302 tobetter identify the fiber channels 407, 409, 410 a-c, 412, 416, 420, 421a-c, 422 and 427 running through the hub 400. The end emitting fibers302 that extend into the proximal connectors 304 of the infusion shafts300 pass through the bottom tray 401 of the hub via fiber channels 407,409 and a respective one of channels 410 a-c. End emitting fiber 338 apasses from the fiber optic umbilical 500 and into the fiber channel 421a in the mid-tray 402 via fiber channels 407, 409, 427, and 422. Each ofend emitting fiber 338 b and 338 c passes from the fiber optic umbilical500 and into its respective fiber channel 421 b and 421 c in themid-tray 402 via fiber channels 407, 409 and 420. In the implementationof FIG. 39A at least a portion of each of the end emitting fibers 338 a,338 b, 338 c overlaps with another one of the end emitting fibers 338 a,338 b, 338 c in one or both of the bottom tray 401 and mid-tray 402.

As shown in FIG. 39A, the distal end of each of the end caps 358 of theend emitting fibers 338 a-c faces distally toward the region where theconduits that join the working lumens of the infusion shafts and mainshaft are to reside. Accordingly, disinfecting light emitted by the endemitting fibers 302 is directed on and through the conduits toeffectuate a disinfecting of the same. For this purpose, the castingmaterial that is ultimately used to encapsulate the hub and to form theconnecting conduits inside the casting is transparent or translucent tothe disinfecting light.

Like with the implementation of FIG. 30, one or more or all of thefibers 302 and 338 a-c is routed in the hub 400 so as not to be tautalong at least a portion of the structures that form the fiber channelslocated in the bottom tray 401. This provision of slack in the one ormore optical fibers guards against excessive tensile forces beingapplied to the fibers when the infusion shafts 300 are bent. This isparticularly important where at least a portion of the optical fiber islongitudinally fixed inside the infusion shaft, like with certainimplementations of the end emitting fibers 302 discussed above.

Fluidly connecting the working lumens 308 of the infusion shafts 300 tothe working lumens 201 a-c of the main shaft 200 may be accomplished ina manner similar to that described above in conjunction with theimplementation of FIG. 30. Like with the implementation of FIG. 30, whenthe casting process is complete, the entirety of the hub 400 may beencapsulated by the casting material and assume an appearance like thatshown in FIG. 3.

To protect against breaking the end emitting fibers, the bends of thefiber channels that contain them are constructed to prevent a bending ofthe optical fibers beyond their minimum bending radius. For example, oneor more or all of the bends of the fiber channels may have a radius ofcurvature that is equal to or greater than the minimum bending radius ofthe optical fiber. The path of the optical fibers about the raisedplatform 408 in the bottom tray 401 may also be selected to ensure thatthe optical fibers do not bend beyond their minimum bending radius. Forthis purpose some of the optical fibers may travel in a clockwisedirection about the raised platform 408, while others travel in acounter-clockwise direction about the raised platform. In theimplementation of FIG. 39A all the end emitting optical fibers travel ina clockwise direction about the raised platform 408 (as viewed fromabove the bottom tray 401) except fiber 358 a that travels in acounter-clockwise direction about the raised platform. The provision ofalternate pathways for the optical fibers to travel around the raisedplatform 408 increases design freedom, particularly in the layout of thebottom tray 401 and mid-tray 402 fiber channels. The provision ofalternate pathways can also facilitate a smaller hub design to provideit with a footprint that is more comparable to the foot print of atraditional CVC hub. As discussed above, by maintaining the disinfectingCVC design similar to traditional CVC designs established clinicalpractices may be followed.

Light reflectors may be incorporated into, attached to or coated on thehub 400 in a manner consistent with that described above in conjunctionwith the implementations of FIG. 30. For example, the casting materialthat surrounds the connecting conduits when the hub is encapsulated mayhave embedded therein one or more light reflecting elements that assistin directing the disinfecting light toward the conduits.

As mentioned above, in certain instances radially emitted disinfectinglight and end emitted disinfecting light may be delivered to certainparts of the CVC by use of a single optical fiber. In theimplementations of both FIGS. 35A and 39A one or more of the endemitting fibers may be substituted with such a fiber to increase thesurface area that is exposed to the disinfecting light. For instance, inthe implementation of FIG. 39A each of fibers 302 may be substitutedwith a dual radial and end emitting fiber. This would result in adisinfection of the connecting conduits with the end emitted light asdiscussed above, and would also result in a disinfection of thoseportions of the infusion shafts that reside below the mid-tray 402 withthe radial emitted light. For this purpose, according to someimplementations at least a portion of the length of the fiber channels421 a-c located in the mid-tray 402 are aligned with the tubular body303 of the infusion shafts 300 located below the mid-tray. Furthermore,because all of the optical fibers in one way or another pass across atleast a portion of the main shaft 200 inside the hub 400, the radialemitted light emanating from these fibers can also be used to cause adisinfecting of the main shaft inside the hub.

In a modified implementation of the CVC of FIG. 35A one or more offibers 337 a-c is a dual radial and end emitting fiber and fibers 302are end emitting fibers. In a like manner, in a modified implementationof the CVC of FIG. 39A one or more of fibers 338 a-c is a dual radialand end emitting fiber and fibers 302 are end emitting fibers.

FIG. 40 depicts a partially constructed hub 470 of a CVC according toanother implementation wherein optical fibers 471 are routed through thehub by use of support fixtures 472 dispersed about and supported on thehub tray 473. The hub is configured to support the distal ends of theinfusion shafts 300 and the proximal end of the main shaft 200. Upon theoptical fibers 471 being properly routed into their respective lumensinside the infusion shafts 300 and/or main shafts 300, the fibers areappropriately covered during a process in which the hub is encased by acasting material. With beadings/mandrels extending between the workinglumens of the infusion shafts 300 and main shaft 200 as described above,the conduits that fluidly connect the working lumens are formed duringthe casting process. The support fixtures 472 are disbursed about thehub in a manner that prevents a bending of one or more or all of theoptical fibers 471 beyond their minimum bending radius. In theimplementations discussed above, one or more of the fiber channels maybe substituted with one or more support fixtures 472 to guide the fibersto their desired destination and in a way that prevents them frombending beyond their minimum bending radius.

According to one implementation the support fixture 472 includes anexpandable elastomeric O-ring 475 that has a top opening/gap 476 throughwhich the optical fibers 471 may be introduced into the O-ring opening477. The elastomeric O-ring is resiliently biased in the position shownin FIG. 41.

The O-ring is supported on a post 478 that is attached to the floor ofthe hub tray 473. Notches 480 in the bottom portion of the O-ringproduce hinges that allow the arms 475 a and 475 b of the O-ring to beflexed outward in opposite directions A and B to increase the size ofthe gap 476 when a downward force is applied to the protruding arms 479located near the base of the O-ring. When the downward applied force tothe arms 479 is released, the arms 475 a and 475 b of the O-ring attemptto return to their original position to lock the optical fibers withinthe opening 477.

As discussed above in conjunction with FIGS. 10B and 10C, according tosome implementations one or more of the infusion shafts 300 are equippedwith dual working lumens 308 a and 308 b that are separated by alongitudinal wall/septum 321. In the aforestated implementations theradially emitting fiber lumen 309 and end emitting fiber lumen 310 arelocated in the septum 321.

In the discussion that follows, apparatus and methods for formingconduits between the respective working lumens of the infusion shafts300 to the working lumens of the main shaft are disclosed. A portion ofthe conduits are formed during a casting process like those describedabove, wherein a casting material is used to encapsulate the hub. Duringthe casting process at least a portion of the length of the conduits isformed with the use of strategically placed mandrels that are envelopedin the casting material during the casting process and ultimatelyremoved.

According to some implementations the apparatus includes a hub 600 thatis adapted to makes use of mandrels 604 a, 604 b to form conduits toconnect the two working lumens 308 a, 308 b of a single infusion shaft300 to a common working lumen inside the main shaft 200. Although thediscussion below is directed primarily to fluidly coupling the twoworking lumens of an infusion shaft 300 c to the working lumen 201 c ofthe main shaft 200, it is appreciated that the working lumens of theother infusion shafts 300 a, 300 b may be coupled with the workinglumens 201 a and 201 b of the main shaft 200 in a similar manner.

According to one implementation the hub 600 includes a tray 601 ontowhich are arranged at a proximal end thereof infusion shaft supportfixtures 605 a-c. The proximal end of the main shaft 200 of the CVCresides inside a manifold 602 located at the distal end of the tray 601.As best seen in FIG. 43, the manifold includes internal conduits 606 a,606 b, 607 a, 607 b, 608 a and 608 b that are fluidly coupled with theworking lumens 201 a-c of the main shaft 200. Internal conduits 606 aand 606 b are fluidly coupled with working lumen 201 a, internalconduits 607 a and 607 b are fluidly coupled with working lumen 201 b,and internal conduits 608 a and 608 b are fluidly coupled with workinglumen 201 c.

The proximal face of the manifold 602 includes mandrel support fixtures610 and 612 that have multiple lumens (e.g. 2 lumens) fluidly coupled tothe internal conduits of the manifold that are respectively coupled tothe working lumens 201 b and 201 c of the main shaft 200. Although notshown in the figures, the manifold 602 may also include a mandrelsupport fixture that has multiple lumens (e.g. 2 lumens) thatcommunicate with the working lumen 201 a of the main shaft 200.

FIG. 44 shows a distal side of the manifold 602 that includes an opening609 into which the proximal end of the main shaft 200 resides when thehub 600 is fully assembled. The opening 609 is in fluid communicationwith each of internal conduits 606 a, 606 b, 607 a, 607 b, 608 a and 608b. According to some implementations the proximal end of the main shaft200 is fixed inside the opening 609 by use of an adhesive. The proximalend of the main shaft may also be press-fit inside the opening 609. Inany event, each of the inlets of the working lumens 201 a-c are alignedwith a respective pair of the internal conduits as shown in FIG. 43.

The mandrel support fixture 612 includes a proximal side 615, a distalside 616 and two through lumens 614 a and 614 b that each extendsbetween the proximal and distal sides. Through lumen 614 a is in fluidcommunication with manifold conduit 608 a and through lumen 614 b is influid communication with manifold conduit 608 b. According to someimplementations the mandrel support fixtures 610 and 612 located on thesides of the manifold 602 each have sloped proximal sides 615. Forexample, as shown in FIGS. 43 and 45B, the outer side 613 a of thefixture 612 has a thickness t1 and the inner side 613 b of the fixture612 has a thickness t2 that is less than the thickness of t1. Thepurpose of the sloped proximal side is discussed below. According tosome implementations fixture 612 is attached to the manifold 602 by theuse of posts 617 that protrude from its distal side 16 into openings(not shown) in the proximal side of the manifold 602.

As briefly mentioned above, a proximal end of the hub tray 601 includesinfusion shaft support fixtures 605 a-c. Each of the infusion shaftsupport fixtures 605 a-c is configured to couple the distal end of aninfusion shaft 300 a-c to the hub 600 and to also accommodate a passageof the mandrels from inside the infusion shafts into the hub 600. When,for example, the mandrels 604 a and 604 b are in place during themanufacturing of the hub 600 as shown in FIGS. 42 and 46, they extendthrough the working lumens 308 a, 308 b of the infusion shaft 300 c,through the infusion shaft support fixture 605 c and into the mandrelsupport fixture 612 located on the manifold 602.

FIGS. 47A and 47B respectively show the proximal and distal sides 622and 624 of the infusion shaft support fixture 605 c according to oneimplementation. The fixture includes first and second through lumens 619a and 619 b that extend between the proximal and distal sides 622 and624. Disposed between lumens 619 a and 619 b is a septum 626 throughwhich two other through lumens 628 a and 628 b pass. According to someimplementations the distal end of the infusion shaft 300 c is attachedto the proximal side 622 of the fixture 605 c by use of a pair of wallsegments 629 a and 629 b that protrude proximally from the septum 626.The wall segments are spaced-apart so that a gap exists between them.Attachment of the proximal end of the infusion shaft 300 c isaccomplished by inserting the septum 321 of the infusion shaft betweenthe spaced-apart wall segments 629 a and 629 b so that the face of theshaft septum 321 abuts the proximal face of the fixture septum 626. Whenthe infusion shaft 300 c is attached to the fixture 605 c the radiallyemitting fiber lumen 309 is axially aligned with lumen 628 a and the endemitting fiber lumen 310 is axially aligned with lumen 628 b. In thisway, optical fibers 301 and 302 may be routed from the fiber opticumbilical 500 and respectively into lumens 628 a and 628 b of thefixture 605 c, and then into the fiber lumens 309 and 310 of theinfusion shaft 300 c. Examples of how the fiber 301 and 302 may resideinside the infusion shaft are discussed above.

According to some implementations, a roundabout 630 is located insidethe hub tray 601 which is used to route the optical fibers to theirdestinations in a manner that prevents the fibers from bending beyondtheir minimum bending radius. For example, fibers 301 and 302 may extendfrom the umbilical hub connector 502 in a counter-clockwise directionabout the roundabout 630 and into their respective lumens 628 a and 628b of the infusion shaft support fixture 605 c. According to someimplementations the radius of curvature of the one or more bends in theroundabout 630 is each greater than the minimum bending radius theoptical fibers 301 and 302. The remainder of the optical fibers may bedelivered to infusion shafts 300 a and 300 b in a similar way, but in aclockwise direction about the roundabout 630.

Upon optical fibers 301 and 302 being placed inside infusion shaft 300c, mandrels 604 a and 604 b may be introduced respectively into theworking lumens 308 a and 308 b through the proximal opening in theproximal connector 304. The lengths of the mandrels are sufficient forthem to pass through the infusion shaft 300 c and through the hub tray601 until their distal ends reside supported in the mandrel supportfixture 612. When the mandrels 604 a and 604 b are in place, each oftheir distal ends respectively resides inside the through lumens 614 aand 614 b of the fixture 612 and their proximal ends reside outside theproximal connector 304 of the infusion shaft 300 c. When the opticalfibers and mandrels for all of the infusions shafts and main shaft arein place, the assembly is cast as discussed above to form anencapsulated hub that has an appearance similar to the hub 400 shown inFIG. 3.

As discussed above the proximal side 615 of the mandrel support fixture612 is sloped. The purpose of the slope is to align the proximal side615 in a plane that is parallel with that of the distal side 624 of theinfusion shaft support fixture 605 c. This provides a direct line ofsight between the lumens 619 a and 619 b of fixture 605 c with thelumens 614 a and 614 b of fixture 612 to allow the placement of straightrigid mandrels between the respective lumens.

While specific implementations and applications have been illustratedand described, it is to be understood that the invention is not limitedto the precise configuration and components disclosed herein. Variousmodifications, changes, and variations which will be apparent to thoseskilled in the art may be made in the arrangement, operation, anddetails of the methods and systems of the present invention disclosedherein without departing from the spirit and scope of the invention.

For example, the disclosure describes in detail various implementationsof a CVC and of its individual components. It is appreciated, however,that the disclosed inventive features are applicable to a host of othertypes of devices inside and outside the medical field. As mentionedabove, the apparatus and methods disclosed herein can also be applied toequipment or components of water processing plants, food processingplants, dairies, livestock habitation facilities, etc.

The following clauses disclose in an unlimited way additionalimplementations, with each clause representing an implementation.Additional implementations are represented by one or more of theimplementations of one group or groups of clauses with one or moreimplementations of another group or groups of clauses. Group A through Hclauses are provided.

Group A clauses:

Clause 1. An assembly comprising:

a first optical fiber having a length;

a first body having a first receptacle in which at least a portion ofthe length of the first optical fiber resides.

Clause 2. The assembly according to clause 1, wherein the first opticalfiber is a radially emitting fiber that is configured to radially emitbacterial disinfecting light to disinfect at least a portion of thefirst body.

Clause 3. The assembly according to clause 1, wherein the first opticalfiber is an end emitting fiber that is configured to end emit bacterialdisinfecting light to disinfect at least a portion of the first body.

Clause 4. The assembly according to clause 1, wherein the first opticalfiber is a radially emitting and end emitting fiber that is configuredto radially emit bacterial disinfecting light to disinfect at least aportion of the first body.

Clause 5. The assembly according to clause 1, wherein the first opticalfiber is a dual emitting fiber that is configured to radially emitbacterial disinfecting light to disinfect at least a first portion ofthe first body and to end emit bacterial disinfecting light to disinfectat least a second portion of the first body.

Clause 6. The assembly according to clause 1, further comprising asecond optical fiber having a length, the first body having a secondreceptacle in which at least a portion of the length of the secondoptical fiber resides.

Clause 7. The assembly according to clause 6, wherein the first opticalfiber is an end emitting fiber that is configured to end emit bacterialdisinfecting light to disinfect at least a first portion of the firstbody, and the second optical fiber is a radially emitting fiber that isconfigured to radially emit bacterial disinfecting light to disinfect atleast a second portion of the first body.

Clause 8. The assembly according to clauses 1, 3 and 7, wherein at leasta portion of the first optical fiber is attached to the first bodyinside the first receptacle.

Clause 9. The assembly according to clauses 1, 2 and 4, wherein thefirst optical fiber is not attached to the first body and is slideableinside the first receptacle.

Clause 10. The assembly according to clauses 3, 5 and 7, wherein thefirst body includes one or more optical surfaces that direct the endemitted bacterial disinfecting light onto the second portion of thefirst body.

Clause 11. The assembly according to clause 6, wherein the secondoptical fiber is an imaging fiber.

Clause 12. The assembly according to clauses 2, 3, 6, 9 and 11, whereinthe first body is a main shaft of a central venous catheter.

Clause 13. The assembly according to clauses 2-7 and 9-10, wherein thefirst body is an infusion shaft of a central venous catheter.

Clause 14. The assembly according to clauses 1-13, wherein the firstbody has a working lumen and an external surface, the external surfacecomprising a light reflective coating that is configured to reflect atleast a portion of the radial emitted disinfecting light into theworking lumen.

Clause 15. The assembly according to clauses 1-13, wherein the firstbody has a working lumen and an external surface, the external surfacehaving disposed thereon a reflective film that is configured to reflectat least a portion of the radial emitted disinfecting light into theworking lumen.

Clause 16. The assembly according to clause 15, wherein the film is heatshrunk onto the external surface of the first body.

Clause 17. The assembly according to clauses 1, 2, 4 and 5-7, whereinthe first body has a working lumen and a light reflector, the lightreflector being embedded in the first body and configured to reflect atleast a portion of the radial emitted disinfecting light into theworking lumen.

Clause 18. The assembly according to clauses 1, 3 and 5-7, wherein thefirst body has a working lumen and a light reflector, the lightreflector being embedded in the first body and configured to reflect atleast a portion of the end emitted disinfecting light into the workinglumen.

Clause 19. The assembly according to clause 7, wherein the first bodyhas a working lumen and a light reflector located between the first andsecond receptacles, the light reflector being embedded in the first bodyand configured to reflect at least a portion of the radially emitteddisinfecting light into the working lumen.

Clause 20. The assembly according to clauses 1-5, wherein a part of thefirst body that contains the first and second optical fibers isresistive to being bent beyond a minimum bending radius of the first andsecond optical fiber.

Clause 21. The assembly according to clauses 3, 5 and 7, wherein thefirst optical fiber comprises at an end thereof a power density loweringend cap.

Group B clauses:

Clause 1. An assembly comprising:

a first optical fiber having a length;

a first body having a receptacle in which at least a first portion ofthe length of the first optical fiber resides;

a second body having formed therein a first channel that houses at leasta second portion of the length of the first optical fiber.

Clause 2. The assembly according to clause 1, wherein the first opticalfiber is a radially emitting fiber that is configured to radially emitbacterial disinfecting light to disinfect at least a portion of thefirst body.

Clause 3. The assembly according to clause 1, wherein the first opticalfiber is a radially emitting fiber that is configured to radially emitbacterial disinfecting light to disinfect at least a portion of thesecond body.

Clause 4. The assembly according to clause 1, wherein the first opticalfiber is a radially emitting fiber that is configured to radially emitbacterial disinfecting light to disinfect at least a portion of thefirst body and at least a portion of the second body.

Clause 5. The assembly according to clause 1, wherein the first opticalfiber is an end emitting fiber that is configured to end emit bacterialdisinfecting light to disinfect at least a portion of the first body.

Clause 6. The assembly according to clause 1, wherein the first opticalfiber is a dual emitting fiber that is configured to radially emitbacterial disinfecting light to disinfect at least a portion of thefirst body.

Clause 7. The assembly according to clause 1, wherein the first opticalfiber is a dual emitting fiber that is configured to radially emitbacterial disinfecting light to disinfect at least a portion of thefirst body and at least a portion of the second body.

Clause 8. The assembly according to clause 1, wherein the first opticalfiber is a dual emitting fiber that is configured to radially emitbacterial disinfecting light to disinfect at least a first portion ofthe first body and to end emit bacterial disinfecting light to disinfectat least a second portion of the first body.

Clause 9. The assembly according to clause 1, wherein the first opticalfiber is a dual emitting fiber that is configured to radially emitbacterial disinfecting light to disinfect at least a first portion ofthe first body and a portion of the second body and to end emitbacterial disinfecting light to disinfect at least a second portion ofthe first body.

Clause 10. The assembly according to clause 1, further comprising asecond optical fiber that has a length, wherein the second body has asecond channel that houses at least a portion of the length of thesecond optical fiber.

Clause 11. The assembly according to clause 10, wherein the firstoptical fiber is a radially emitting fiber that is configured toradially emit bacterial disinfecting light to disinfect at least aportion of the first body and the second optical fiber is a radiallyemitting fiber that is configured to radially emit bacterialdisinfecting light to disinfect at least a first portion of the secondbody.

Clause 12. The assembly according to clause 11, wherein the firstoptical fiber is configured to radially emit bacterial disinfectinglight to disinfect at least a second portion of the second body.

Clause 13. The assembly according to clause 10, wherein the firstoptical fiber is an end emitting fiber that is configured to end emitbacterial disinfecting light to disinfect at least a first portion ofthe first body, and the second optical fiber is a radially emittingfiber that is configured to radially emit bacterial disinfecting lightto disinfect at least a second portion of the first body.

Clause 14. The assembly according to clause 10, wherein the firstoptical fiber is an end emitting fiber that is configured to end emitbacterial disinfecting light to disinfect at least a first portion ofthe first body, and the second optical fiber is a radially emittingfiber that is configured to radially emit bacterial disinfecting lightto disinfect at least a second portion of the first body and a portionof the second body.

Clause 15. The assembly according to clause 10, wherein the firstoptical fiber is an end emitting fiber that is configured to end emitbacterial disinfecting light to disinfect at least a first portion ofthe first body, and the second optical fiber is also an end emittingfiber that is configured to end emit bacterial disinfecting light todisinfect at least a portion of the second body.

Clause 16. The assembly according to clause 10, wherein the secondoptical fiber is configured to end emit bacterial disinfecting light todisinfect at least a portion of the first body.

Clause 17. The assembly according to clause 10, wherein the firstoptical fiber is a dual emitting fiber that is configured to radiallyemit bacterial disinfecting light to disinfect at least a first portionof the first body and to end emit bacterial disinfecting light todisinfect at least a second portion of the first body, the secondoptical fiber being a dual emitting fiber that is configured to radiallyemit bacterial disinfecting light to disinfect at least a first portionof the second body and to end emit bacterial disinfecting light todisinfect at least a second portion of the second body.

Clause 18. The assembly according to clause 10, wherein the firstoptical fiber is a dual emitting fiber that is configured to radiallyemit bacterial disinfecting light to disinfect at least a first portionof the first body and to end emit bacterial disinfecting light todisinfect at least a second portion of the first body, the secondoptical fiber being a radially emitting fiber that is configured toradially emit bacterial disinfecting light to disinfect at least aportion of the second body.

Clause 19. The assembly according to clause 10, wherein the firstoptical fiber is a dual emitting fiber that is configured to radiallyemit bacterial disinfecting light to disinfect at least a first portionof the first body and to end emit bacterial disinfecting light todisinfect at least a second portion of the first body, the secondoptical fiber being an end emitting fiber that is configured to end emitbacterial disinfecting light to disinfect at least a portion of thesecond body.

Clause 20. The assembly according to clause 10, wherein a portion of thesecond channel overlaps a portion of the first channel.

Clause 21. The assembly according to clause 10, wherein the first bodyis a flexible structure and the second body is a rigid structure.

Clause 22. The assembly according to clause 1, wherein the first body isa flexible structure and the second body is a rigid structure.

Clause 23. The assembly according to clauses 1-22, wherein at least aportion of the first optical fiber is attached to the first body insidethe receptacle.

Clause 24. The assembly according to clauses 1-22, wherein the firstoptical fiber is not attached to the first body and is slideable insidethe receptacle.

Clause 25. The assembly according to clauses 1-24, wherein the at leastsecond portion of the length of the first optical fiber is not held tautalong at least a portion of the length of the first channel.

Clause 26. The assembly according to clauses 10-24, wherein the at leastsecond portion of the length of the first optical fiber is not held tautalong at least a portion of the length of the first channel and the atleast second portion of the length of the second optical fiber is notheld taut along at least a portion of the length of the second channel.

Clause 27. The assembly according to clause 10-22, wherein at least aportion of the length of the first channel and at least a portion of thelength of the second channel reside at different heights inside thesecond body.

Clause 28. The assembly according to clause 10-22, wherein the secondbody comprises a raised platform that has side walls that at leastpartially define the first and second channels, the first optical fiberbeing routed inside the second body in a clockwise direction around theraised platform and the second optical fiber being routed inside thesecond body in a counter-clockwise direction around the raised platform.

Clause 29. The assembly according to clauses 5 and 13-19, furthercomprising one or more optical surfaces that direct the end emittedbacterial disinfecting light onto the first body.

Clause 30. The assembly according to clauses 15-17 and 19, furthercomprising one or more optical surfaces that direct the end emittedbacterial disinfecting light onto the second body.

Clause 31. The assembly according to clauses 1-27, wherein the firstbody and second body are respectively a main shaft and a hub of acentral venous catheter.

Clause 32. The assembly according to clauses 1-27, wherein the firstbody and second body are respectively an infusion shaft and a hub of acentral venous catheter.

Clause 33. The assembly according to clause 31, further comprising aninfusion shaft, the infusion shaft and main shaft being fluidly coupledinside the hub by a conduit.

Clause 34. The assembly according to clause 33, wherein at least aportion of one of the first channel and second channel resides above,below or to the side of the conduit.

Clause 35. The assembly according to clauses 3, 5 and 7, wherein the endemitting fiber comprises at an end thereof a power density lowering endcap.

Clause 36. An assembly comprising:

an end emitting optical fiber having a length;

a body having formed therein a channel that houses at least a portion ofthe length of the end emitting optical fiber, the end emitting opticalfiber configured to end emit bacterial disinfecting light to disinfectat least a portion of the first body.

Group C clauses:

Clause 1. An assembly comprising:

a first optical fiber having a length and a first minimum bendingradius;

a first body having a receptacle in which at least a first portion ofthe length of the first optical fiber resides;

a second body attached to the first body, the second body having formedtherein a first channel that houses at least a second portion of thelength of the first optical fiber, the first channel having a length andone or more bends along the length, each of the one or more bends havinga radius of curvature that is equal to or greater than the first minimumbending radius of the first optical fiber.

Clause 2. The assembly according to clause 1, wherein the first opticalfiber is a radially emitting fiber that is configured to radially emitbacterial disinfecting light to disinfect at least a portion of thefirst body.

Clause 3. The assembly according to clause 1, wherein the first opticalfiber is a radially emitting fiber that is configured to radially emitbacterial disinfecting light to disinfect at least a portion of thesecond body.

Clause 4. The assembly according to clause 1, wherein the first opticalfiber is a radially emitting fiber that is configured to radially emitbacterial disinfecting light to disinfect at least a portion of thefirst body and at least a portion of the second body.

Clause 5. The assembly according to clause 1, wherein the first opticalfiber is an end emitting fiber that is configured to end emit bacterialdisinfecting light to disinfect at least a portion of the first body.

Clause 6. The assembly according to clause 1, wherein the first opticalfiber is a dual emitting fiber that is configured to radially emitbacterial disinfecting light to disinfect at least a portion of thefirst body.

Clause 7. The assembly according to clause 1, wherein the first opticalfiber is a dual emitting fiber that is configured to radially emitbacterial disinfecting light to disinfect at least a portion of thefirst body and at least a portion of the second body.

Clause 8. The assembly according to clause 1, wherein the first opticalfiber is a dual emitting fiber that is configured to radially emitbacterial disinfecting light to disinfect at least a first portion ofthe first body and to end emit bacterial disinfecting light to disinfectat least a second portion of the first body.

Clause 9. The assembly according to clause 1, wherein the first opticalfiber is a dual emitting fiber that is configured to radially emitbacterial disinfecting light to disinfect at least a first portion ofthe first body and a portion of the second body and to end emitbacterial disinfecting light to disinfect at least a second portion ofthe first body.

Clause 10. The assembly according to clause 1, further comprising asecond optical fiber that has a length and a second minimum bendingradius, wherein the second body has a second channel that houses atleast a portion of the length of the second optical fiber, the secondchannel having a length and one or more bends along the length, each ofthe one or more bends of the second channel having a radius of curvaturethat is equal to or greater than the second minimum bending radius ofthe second optical fiber.

Clause 11. The assembly according to clause 10, wherein the firstoptical fiber is a radially emitting fiber that is configured toradially emit bacterial disinfecting light to disinfect at least aportion of the first body and the second optical fiber is a radiallyemitting fiber that is configured to radially emit bacterialdisinfecting light to disinfect at least a first portion of the secondbody.

Clause 12. The assembly according to clause 11, wherein the firstoptical fiber is configured to radially emit bacterial disinfectinglight to disinfect at least a second portion of the second body.

Clause 13. The assembly according to clause 10, wherein the firstoptical fiber is an end emitting fiber that is configured to end emitbacterial disinfecting light to disinfect at least a first portion ofthe first body, and the second optical fiber is a radially emittingfiber that is configured to radially emit bacterial disinfecting lightto disinfect at least a second portion of the first body.

Clause 14. The assembly according to clause 10, wherein the firstoptical fiber is an end emitting fiber that is configured to end emitbacterial disinfecting light to disinfect at least a first portion ofthe first body, and the second optical fiber is a radially emittingfiber that is configured to radially emit bacterial disinfecting lightto disinfect at least a second portion of the first body and a portionof the second body.

Clause 15. The assembly according to clause 10, wherein the firstoptical fiber is an end emitting fiber that is configured to end emitbacterial disinfecting light to disinfect at least a first portion ofthe first body, and the second optical fiber is also an end emittingfiber that is configured to end emit bacterial disinfecting light todisinfect at least a portion of the second body.

Clause 16. The assembly according to clause 10, wherein the secondoptical fiber is also configured to end emit bacterial disinfectinglight to disinfect at least a portion of the first body.

Clause 17. The assembly according to clause 10, wherein the firstoptical fiber is a dual emitting fiber that is configured to radiallyemit bacterial disinfecting light to disinfect at least a first portionof the first body and to end emit bacterial disinfecting light todisinfect at least a second portion of the first body, the secondoptical fiber being a dual emitting fiber that is configured to radiallyemit bacterial disinfecting light to disinfect at least a first portionof the second body and to end emit bacterial disinfecting light todisinfect at least a second portion of the second body.

Clause 18. The assembly according to clause 10, wherein the firstoptical fiber is a radially dual emitting fiber that is configured toradially emit bacterial disinfecting light to disinfect at least a firstportion of the first body and to end emit bacterial disinfecting lightto disinfect at least a second portion of the first body, the secondoptical fiber being a radially emitting fiber that is configured toradially emit bacterial disinfecting light to disinfect at least aportion of the second body.

Clause 19. The assembly according to clause 10, wherein the firstoptical fiber is a dual emitting fiber that is configured to radiallyemit bacterial disinfecting light to disinfect at least a first portionof the first body and to end emit bacterial disinfecting light todisinfect at least a second portion of the first body, the secondoptical fiber being an end emitting fiber that is configured to end emitbacterial disinfecting light to disinfect at least a portion of thesecond body.

Clause 20. The assembly according to clause 10, wherein a portion of thesecond channel overlaps a portion of the first channel.

Clause 21. The assembly according to clause 10, wherein the first bodyis a flexible structure and the second body is a rigid structure.

Clause 22. The assembly according to clause 1, wherein the first body isa flexible structure and the second body is a rigid structure.

Clause 23. The assembly according to clauses 1-22, wherein at least aportion of the first optical fiber is attached to the first body insidethe receptacle.

Clause 24. The assembly according to clauses 1-22, wherein the firstoptical fiber is not attached to the first body and is slideable insidethe receptacle.

Clause 25. The assembly according to clauses 1-24, wherein the at leastsecond portion of the length of the first optical fiber is not held tautalong at least a portion of the length of the first channel so that thefirst optical fiber possesses slack.

Clause 26. The assembly according to clauses 10-24, wherein the at leastsecond portion of the length of the first optical fiber is not held tautalong at least a portion of the length of the first channel and the atleast second portion of the length of the second optical fiber is notheld taut along at least a portion of the length of the second channel.

Clause 27. The assembly according to clause 10-22, wherein at least aportion of the length of the first channel and at least a portion of thelength of the second channel reside at different heights inside thesecond body.

Clause 28. The assembly according to clause 10-22, wherein the secondbody comprises a raised platform that has side walls that at leastpartially define the first and second channels, the first optical fiberbeing routed inside the second body in a clockwise direction around theraised platform and the second optical fiber being routed inside thesecond body in a counter-clockwise direction around the raised platform.

Clause 29. The assembly according to clauses 5 and 13-19, furthercomprising one or more optical surfaces through which the end emittedbacterial disinfecting light passes before the bacterial disinfectinglight is delivered to the first body.

Clause 30. The assembly according to clauses 15-17 and 19, furthercomprising one or more optical surfaces through which the end emittedbacterial disinfecting light passes before the bacterial disinfectinglight is delivered to the first body.

Clause 31. The assembly according to clauses 1-27, wherein the firstbody and second body are respectively a main shaft and a hub of acentral venous catheter.

Clause 32. The assembly according to clauses 1-27, wherein the firstbody and second body are respectively an infusion shaft and a hub of acentral venous catheter.

Clause 33. The assembly according to clause 32, further comprising aninfusion shaft, the infusion shaft and main shaft being fluidly coupledinside the hub by a conduit.

Clause 34. The assembly according to clause 33, wherein at least aportion of one of the first channel or second channel resides above,below or to the side of the tubular conduit.

Clause 35. An assembly comprising:

an end emitting optical fiber having a length and a minimum bendingradius;

a body having formed therein a channel that houses at least a portion ofthe length of the end emitting optical fiber, the channel having alength and one or more bends along the length, each of the one or morebends having a radius of curvature that is equal to or greater than theminimum bending radius of the end emitting optical fiber, the endemitting optical fiber configured to end emit bacterial disinfectinglight to disinfect at least a portion of the first body.

Group D clauses:

Clause 1. An assembly comprising:

a first optical fiber having a length;

a first body having a receptacle in which at least a first portion ofthe length of the first optical fiber resides;

a second body in which a portion of the first body resides, the secondbody having formed therein a first channel that houses at least a secondportion of the length of the first optical fiber;

wherein the at least second portion of the length of the first opticalfiber is not held taut along at least a portion of the length of thefirst channel so that the first optical fiber possesses slack.

Clause 2. The assembly according to clause 1, wherein the first opticalfiber is a radially emitting fiber that is configured to radially emitbacterial disinfecting light to disinfect at least a portion of thefirst body.

Clause 3. The assembly according to clause 1, wherein the first opticalfiber is a radially emitting fiber that is configured to radially emitbacterial disinfecting light to disinfect at least a portion of thesecond body.

Clause 4. The assembly according to clause 1, wherein the first opticalfiber is a radially emitting fiber that is configured to radially emitbacterial disinfecting light to disinfect at least a portion of thefirst body and at least a portion of the second body.

Clause 5. The assembly according to clause 1, wherein the first opticalfiber is an end emitting fiber that is configured to end emit bacterialdisinfecting light to disinfect at least a portion of the first body.

Clause 6. The assembly according to clause 1, wherein the first opticalfiber is a dual emitting fiber that is configured to radially emitbacterial disinfecting light to disinfect at least a portion of thefirst body.

Clause 7. The assembly according to clause 1, wherein the first opticalfiber is a dual emitting fiber that is configured to radially emitbacterial disinfecting light to disinfect at least a portion of thefirst body and at least a portion of the second body.

Clause 8. The assembly according to clause 1, wherein the first opticalfiber is a dual emitting fiber that is configured to radially emitbacterial disinfecting light to disinfect at least a first portion ofthe first body and to end emit bacterial disinfecting light to disinfectat least a second portion of the first body.

Clause 9. The assembly according to clause 1, wherein the first opticalfiber is a dual emitting fiber that is configured to radially emitbacterial disinfecting light to disinfect at least a first portion ofthe first body and a portion of the second body, and to end emitbacterial disinfecting light to disinfect at least a second portion ofthe first body.

Clause 10. The assembly according to clause 1, further comprising asecond optical fiber that has a length and the second body has a secondchannel that houses at least a portion of the length of the secondoptical fiber;

wherein the at least second portion of the length of the first opticalfiber is not held taut along at least a portion of the length of thefirst channel and the at least second portion of the length of thesecond optical fiber is not held taut along at least a portion of thelength of the second channel.

Clause 11. The assembly according to clause 10, wherein the firstoptical fiber is a radially emitting fiber that is configured toradially emit bacterial disinfecting light to disinfect at least aportion of the first body and the second optical fiber is a radiallyemitting fiber that is configured to radially emit bacterialdisinfecting light to disinfect at least a first portion of the secondbody.

Clause 12. The assembly according to clause 11, wherein the firstoptical fiber is configured to radially emit bacterial disinfectinglight to disinfect at least a second portion of the second body.

Clause 13. The assembly according to clause 10, wherein the firstoptical fiber is an end emitting fiber that is configured to end emitbacterial disinfecting light to disinfect at least a first portion ofthe first body, and the second optical fiber is a radially emittingfiber that is configured to radially emit bacterial disinfecting lightto disinfect at least a second portion of the first body.

Clause 14. The assembly according to clause 10, wherein the firstoptical fiber is an end emitting fiber that is configured to end emitbacterial disinfecting light to disinfect at least a first portion ofthe first body, and the second optical fiber is a radially emittingfiber that is configured to radially emit bacterial disinfecting lightto disinfect at least a second portion of the first body and a portionof the second body.

Clause 15. The assembly according to clause 10, wherein the firstoptical fiber is an end emitting fiber that is configured to end emitbacterial disinfecting light to disinfect at least a first portion ofthe first body, and the second optical fiber is also an end emittingfiber that is configured to end emit bacterial disinfecting light todisinfect at least a portion of the second body.

Clause 16. The assembly according to clause 10, wherein the secondoptical fiber is also configured to end emit bacterial disinfectinglight to disinfect at least a portion of the first body.

Clause 17. The assembly according to clause 10, wherein the firstoptical fiber is a dual emitting fiber that is configured to radiallyemit bacterial disinfecting light to disinfect at least a first portionof the first body and to end emit bacterial disinfecting light todisinfect at least a second portion of the first body, the secondoptical fiber being a dual emitting fiber that is configured to radiallyemit bacterial disinfecting light to disinfect at least a first portionof the second body and to end emit bacterial disinfecting light todisinfect at least a second portion of the second body.

Clause 18. The assembly according to clause 10, wherein the firstoptical fiber is a dual emitting fiber that is configured to radiallyemit bacterial disinfecting light to disinfect at least a first portionof the first body and to end emit bacterial disinfecting light todisinfect at least a second portion of the first body, the secondoptical fiber being a radially emitting fiber that is configured toradially emit bacterial disinfecting light to disinfect at least aportion of the second body.

Clause 19. The assembly according to clause 10, wherein the firstoptical fiber is a dual emitting fiber that is configured to radiallyemit bacterial disinfecting light to disinfect at least a first portionof the first body and to end emit bacterial disinfecting light todisinfect at least a second portion of the first body, the secondoptical fiber being an end emitting fiber that is configured to end emitbacterial disinfecting light to disinfect at least a portion of thesecond body.

Clause 20. The assembly according to clause 10, wherein a portion of thesecond channel overlaps a portion of the first channel.

Clause 21. The assembly according to clause 10, wherein the first bodyis a flexible structure and the second body is a rigid structure.

Clause 22. The assembly according to clause 1, wherein the first body isa flexible structure and the second body is a rigid structure.

Clause 23. The assembly according to clauses 1-22, wherein at least aportion of the first optical fiber is attached to the first body insidethe receptacle.

Clause 24. The assembly according to clauses 1-22, wherein the firstoptical fiber is not attached to the first body and is slideable insidethe receptacle.

Clause 25. The assembly according to clause 10-22, wherein at least aportion of the length of the first channel and at least a portion of thelength of the second channel reside at different heights inside thesecond body.

Clause 26. The assembly according to clause 10-22, wherein the secondbody comprises a raised platform that has side walls that at leastpartially define the first and second channels, the first optical fiberbeing routed inside the second body in a clockwise direction around theraised platform and the second optical fiber being routed inside thesecond body in a counter-clockwise direction around the raised platform.

Clause 27. The assembly according to clauses 5 and 13-19, furthercomprising one or more optical surfaces through which the end emittedbacterial disinfecting light passes before the bacterial disinfectinglight is delivered to the first body.

Clause 28. The assembly according to clauses 15-17 and 19, furthercomprising one or more optical surfaces through which the end emittedbacterial disinfecting light passes before the bacterial disinfectinglight is delivered to the first body.

Clause 29. The assembly according to clauses 1-26, wherein the firstbody and second body are respectively a main shaft and a hub of acentral venous catheter.

Clause 30. The assembly according to clauses 1-26, wherein the firstbody and second body are respectively an infusion shaft and a hub of acentral venous catheter.

Clause 31. The assembly according to clause 29, further comprising aninfusion shaft, the infusion shaft and main shaft being fluidly coupledinside the hub by a conduit.

Clause 32. The assembly according to clause 31, wherein at least aportion of one of the first channel or second channel resides above,below or to the side of the conduit.

Clause 33. An assembly comprising:

an end emitting optical fiber having a length;

a body having formed therein a channel that houses at least a portion ofthe length of the end emitting optical fiber, the end emitting opticalfiber being configured to end emit bacterial disinfecting light todisinfect at least a portion of the second body;

wherein the at least portion of the length of the end emitting opticalfiber is not held taut along at least a portion of the length of thechannel.

Group E clauses:

Clause 1. An assembly comprising:

an end emitting optical fiber having a length and configured to end emitbacterial disinfecting light;

a body having a receptacle in which at least a portion of the length ofthe end emitting optical fiber resides, the body having a disinfectingtarget area located therein;

one or more surfaces disposed on or in the body onto which the endemitted bacterial disinfecting light is configured to impinge when theend emitting light is activated, the one or more surfaces beingconfigured to alter the trajectory of the disinfecting light so that thedisinfecting light is directed toward the disinfecting target area via adisinfecting light pathway.

Clause 2. The assembly according to clause 1, wherein at least one ofthe one or more surfaces comprises a refractive optical surface.

Clause 3. The assembly according to clause 1, wherein at least one ofthe one or more surfaces comprises a total internal reflection opticalsurface.

Clause 4. The assembly according to clause 1, wherein at least one ofthe one or more surfaces comprises a light reflector.

Clause 5. The assembly according to clause 1, wherein the one or moresurfaces comprise a refractive optical surface and a total internalreflection optical surface.

Clause 6. The assembly according to clause 1, wherein the one or moresurfaces comprise a refractive optical surface and a light reflector.

Clause 7. The assembly according to clause 1, wherein the one or moresurfaces comprise a total internal reflection optical surface and alight reflector.

Clause 8. The assembly according to clause 1, wherein the one or moresurfaces comprise a refractive optical surface, a total internalreflection optical surface and a light reflector.

Clause 9. The assembly according to clause 2, wherein the at least onerefractive optical surface is configured to collimate the disinfectinglight.

Clause 10. The assembly according to clause 2, wherein the least onerefractive optical surface is configured to converge the disinfectinglight.

Clause 11. The assembly according to clause 2, wherein the least onerefractive optical surface is configured to diverge the disinfectinglight.

Clause 12. The assembly according to clause 2, wherein the least onerefractive optical surface is flat.

Clause 13. The assembly according to clause 2, wherein the least onerefractive optical surface has a semi-spherical shape.

Clause 14. The assembly according to clause 2, wherein the least onerefractive optical surface has an a-spherical shape.

Clause 15. The assembly according to clause 5, wherein the refractiveoptical surface precedes the total internal reflection optical surfacein the disinfecting light pathway.

Clause 16. The assembly according to clause 6, wherein the refractiveoptical surface precedes the light reflector in the disinfecting lightpathway.

Clause 17. The assembly according to clause 7, wherein the totalinternal reflection optical surface precedes the light reflector in thedisinfecting light pathway.

Clause 18. The assembly according to clause 8, wherein the refractiveoptical surface precedes the total internal reflection optical surfacewhich precedes the light reflector in the disinfecting light pathway.

Clause 19. The assembly according to clause 2, wherein the end emittingoptical fiber comprises a core having an end with there being an indexmatching material disposed between the end of the core and therefractive optical surface.

Clause 20. The assembly according to clause 19, wherein the indexmatching material is an adhesive that secures the end emitting opticalfiber to the body.

Clause 21. The assembly according to clause 1, wherein the bodycomprises a part of an infusion shaft of a central venous catheter.

Clause 22. The assembly according to clause 21, wherein the partcomprises a proximal connector of the infusion shaft.

Clause 23. The assembly according to clauses 1-22, wherein the endemitting fiber comprises at an end thereof a power density lowering endcap.

Group F clauses:

Clause 1. An assembly comprising:

an elongate shaft having a longitudinal axis and an outer surface;

a radially emitting fiber spirally disposed inside the elongate shaft;

a plurality of through holes located between the radially emitting fiberand the outer surface, the through holes being longitudinallyspaced-apart from one another;

a laser optically coupled with the radially emitting fiber;

a controller operatively coupled to the laser and configured to causethe laser to deliver pulsed light with a pulsed width into the radiallyemitting fiber, a longitudinal distance between adjacent through holesbeing such that the pulse width is shorter than a time for the light totravel between the adjacent through holes.

Clause 2. The assembly according to clause 1, further comprising a backreflectance detector that is optically coupled to the radially emittingfiber and configured to receive back reflected light pulses from theradially emitting fiber.

Clause 3. The assembly according to clause 2, wherein the light sourceis a laser that is optically coupled to the radially emitting fiber andconfigured to deliver the pulsed light to the radially emitting fibervia a mirror.

Clause 4. The assembly according to clause 3, wherein the mirror is alsoconfigured to direct the back reflected light pulses to the backreflectance detector.

Clause 5. The assembly according to clause 2, wherein the backreflectance detector is configured to generate data based upon the backreflected light pulses received in the back reflectance detector.

Clause 6. The assembly according to clause 5, wherein the backreflectance detector comprises means for comparing the data withbaseline data to determine if an unwanted substance exists on the outersurface of the elongate shaft.

Clause 7. The assembly according to clause 5, wherein the backreflectance detector comprises means for processing the data to form animage that can be used to determine if an unwanted substance exists onthe outer surface of the elongate shaft.

Clause 8. The assembly according to clause 6, wherein the unwantedsubstance is a biofilm or a clot.

Clause 9. The assembly according to clause 1, wherein the elongate shaftcomprises a wall that extends between an inner surface and the outersurface, the inner surface defining a lumen that runs along a length ofthe elongate shaft.

Clause 10. The assembly according to clause 1, wherein the radiallyemitting fiber is fixed inside the elongate shaft.

Clause 11. The assembly according to clause 1, wherein the radiallyemitting fiber is disposed inside a spiral lumen inside a length of theelongate shaft, the radially emitting fiber being slideable inside thelumen.

Clause 12. The assembly according to clause 1 comprising a singleradially emitting fiber.

Clause 13. The assembly according to clause 1, wherein the radiallyemitting fiber is located nearer the outer surface of the elongate shaftthan to the longitudinal axis of the elongate shaft.

Clause 14. The assembly according to clause 1, wherein the laser isconfigured to emit red light.

Clause 15. A method of determining the presence of an unwanted substanceon the outer surface of an elongate shaft, the elongate shaft includinga longitudinal axis, an outer surface, a radially emitting fiberspirally disposed inside the elongate shaft, and a plurality of throughholes located between the radially emitting fiber and the outer surface,the through holes being longitudinally spaced-apart from one another,the method comprising:

emitting pulsed light having a pulsed width from the radially emittingfiber so that at least a portion of the pulsed light is deliveredthrough the plurality of through holes;

sequentially receiving in the radially emitting fiber through theplurality of through holes a plurality of back reflected light pulses;

delivering the plurality of back reflected light pulses to a backreflective detector;

generating data that correlates with the plurality of back reflectedlight pulses.

Clause 16. The method according to clause 15, further comprisingcomparing the data with baseline data to determine if an unwantedsubstance exists on the outer surface of the elongate shaft.

Clause 17. The method according to clause 15, further comprising meansfor processing the data to form an image that can be used to determineif an unwanted substance exists on the outer surface of the elongateshaft.

Clause 18. The method according to clause 15, wherein the elongate shafthas a proximal end and a distal end, and the plurality of through holesincludes a proximal-most through hole, a distal-most through hole andone or more through holes dispersed there between, the plurality of backreflected pulses being delivered to the back reflective detectorsequentially beginning with the back reflected pulse received in theradially emitting fiber through the proximal-most through hole andending with the back reflected pulse received in the radially emittingfiber through the distal-most through hole.

Clause 19. The method according to clause 15, further comprisingdelivery light from a laser to the radially emitting fiber via a mirrorand delivering the plurality of back reflected pulses to the backreflectance detector via the mirror.

Clause 20. The method according to clause 19, wherein the light is redlight.

Group G clauses:

Clause 1. A hub comprising:

a first optical fiber, the first optical fiber having a length and afirst minimum bending radius;

a first channel that houses at least a portion of the length of thefirst optical fiber, the first channel having a length and one or morebends along the length, each of the one or more bends having a radius ofcurvature that is equal to or greater than the first minimum bendingradius of the first optical fiber.

Clause 2. The hub according to clause 1, wherein the first optical fiberis a radially emitting fiber that is configured to emit bacterialdisinfecting light to disinfect at least a portion of the hub.

Clause 3. The hub according to clause 1, wherein the first optical fiberis an end emitting fiber that is configured to emit bacterialdisinfecting light to disinfect at least a portion of the hub.

Clause 4 The hub according to clause 3, further comprising a proximalend portion of a main shaft, the main shaft including a working lumenthat has a proximal opening located inside the hub, the end emittingfiber being configured to the emit bacterial disinfecting light todisinfect at least a portion of the proximal end portion of the mainshaft.

Clause 5. The hub according to clause 1, further comprising:

a distal end portion of an infusion shaft, the infusion shaft includinga working lumen that has a distal opening located inside the hub;

a proximal end portion of a main shaft, the main shaft including aworking lumen that has a proximal opening located inside the hub;

a conduit that fluidly couples the distal opening of the working lumenof the infusion shaft to the proximal opening of the working lumen ofthe main shaft, the conduit having a length;

at least a portion of the length of the first channel that houses thefirst optical fiber being located above, below or to the side of atleast a portion of the length of the conduit.

Clause 6. The hub according to clause 5, wherein the first optical fiberis a radially emitting fiber that is configured to emit a bacterialdisinfecting light and to expose the conduit to the bacterialdisinfecting light.

Clause 7. The hub according to clause 1, further comprising:

a distal end portion of an infusion shaft, the infusion shaft includinga working lumen that has a distal opening located inside the hub;

a proximal end portion a main shaft, the main shaft including a workinglumen that has a proximal opening located inside the hub;

a conduit that fluidly couples the distal opening of the working lumenof the infusion shaft to the proximal opening of the working lumen ofthe main shaft, the conduit having a length;

wherein the first optical fiber is an end emitting fiber that isconfigured to emit bacterial disinfecting light to disinfect at least aportion of the hub.

Clause 8. The hub according to clause 6, wherein the conduit comprises atubular body that is transparent or translucent to the bacterialdisinfecting light.

Clause 9. The hub according to clause 1, further comprising:

a distal end portion of an infusion shaft, the infusion shaft includinga working lumen that has a distal opening located inside the hub;

a proximal end portion a main shaft, the main shaft including a workinglumen that has a proximal opening located inside the hub;

a conduit that fluidly couples the distal opening of the working lumenof the infusion shaft to the proximal opening of the working lumen ofthe main shaft, the conduit having a length;

at least a portion of the length of the first channel that houses thefirst optical fiber being located above or below at least a portion of alength of the working lumen located in the distal portion of theinfusion shaft.

Clause 10. The hub according to clause 9, wherein the first opticalfiber is a radially emitting fiber that is configured to emit abacterial disinfecting light and to expose the at least portion of thelength of the working lumen of the infusion shaft to the bacterialdisinfecting light.

Clause 11. The hub according to clause 9, wherein the first opticalfiber is an end emitting fiber that is configured to emit a bacterialdisinfecting light and to expose the at least portion of the length ofthe working lumen of the infusion shaft to the bacterial disinfectinglight.

Clause 12. The hub according to clause 10, wherein the at least portionof the length of the working lumen of the infusion shaft resides insidea tubular body that is transparent or translucent to the bacterialdisinfecting light.

Clause 13. The hub according to clause 11, wherein the at least portionof the length of the working lumen of the infusion shaft resides insidea tubular body, the tubular body having an opening through which thebacterial disinfecting light is configured to propagate into the workinglumen.

Clause 14. The hub according to clause 11, further comprising one ormore optical surfaces through which the bacterial disinfecting lightemitted by the end emitting fiber passes before the bacterialdisinfecting light is delivered to the at least portion of the length ofthe working lumen of the infusion shaft.

Clause 15. The hub according to clause 5, wherein the distal end portionof the infusion shaft includes a fiber lumen that contains at least aportion of the first optical fiber.

Clause 16. The hub according to clause 15, wherein the first opticalfiber is a radially emitting fiber that is configured to emit bacterialdisinfecting light.

Clause 17. The hub according to clause 15, wherein the first opticalfiber is an end emitting fiber that is configured to emit bacterialdisinfecting light.

Clause 18. The hub according to clause 9, wherein the proximal endportion of the main shaft includes a fiber lumen that contains at leasta portion of the first optical fiber.

Clause 19. The hub according to clause 18, wherein the first opticalfiber is a radially emitting fiber that is configured to emit bacterialdisinfecting light.

Clause 20. The hub according to clause 18, wherein the first opticalfiber is an end emitting fiber that is configured to emit bacterialdisinfecting light.

Clause 21. The hub according to clause 5, further comprising:

a second optical fiber, the second optical fiber having a length and asecond minimum bending radius;

a second channel that houses at least a portion of the length of thesecond optical fiber, the second channel having a length and one or morebends along the length, each of the one or more bends having a radius ofcurvature that is equal to or greater than the second minimum bendingradius of the second optical fiber;

at least a portion of the length of the second channel that houses thesecond optical fiber being located above or below at least a portion ofa length of the working lumen located in the distal portion of theinfusion shaft.

Clause 22. The hub according to clause 21, wherein at least a portion ofthe length of the first channel and at least a portion of the length ofthe second channel overlap.

Clause 23. The hub according to clause 21, wherein at least a portion ofthe length of the second channel resides vertically above at least aportion of the length of the first channel.

Clause 24. The hub according to clause 21, wherein each of the first andsecond optical fibers is a radially emitting fiber that is configured toemit bacterial disinfecting light.

Clause 25. The hub according to clause 21, wherein each of the first andsecond optical fibers is an end emitting fiber that is configured toemit bacterial disinfecting light.

Clause 26. The hub according to clause 21, wherein the first opticalfiber is a radially emitting fiber that is configured to emit bacterialdisinfecting light and the second optical fiber is an end-emitting fiberthat is configured to emit bacterial emitting light.

Clause 27. The hub according to clause 24, wherein the proximal endportion of the main shaft includes a fiber lumen that contains at leasta portion of the second optical fiber.

Clause 28. The hub according to clause 24, wherein the distal endportion of the infusion shaft includes a fiber lumen that contains atleast a portion of the first optical fiber.

Clause 29. The hub according to clause 27, wherein the distal endportion of the infusion shaft includes a fiber lumen that contains atleast a portion of the first optical fiber.

Clause 30. The hub according to clause 1, further comprising:

a distal end portion of an infusion shaft, the infusion shaft includinga working lumen that has a distal opening located inside the hub;

a proximal end portion a main shaft, the main shaft including a workinglumen that has a proximal opening located inside the hub, the proximalend portion of the main shaft having a fiber lumen;

a conduit that fluidly couples the distal opening of the working lumenof the infusion shaft to the proximal opening of the working lumen ofthe main shaft, the conduit having a length;

wherein the first optical fiber is an imaging fiber, at least a portionof a length of the imaging fiber residing inside the fiber lumen.

Clause 31. The hub according to clause 1, wherein the first opticalfiber is not held taut along at least a portion of the length of thefirst channel.

Clause 32. The hub according to clause 5, wherein the first opticalfiber is not held taut along at least a portion of the length of thefirst channel.

Clause 33. The hub according to clause 21, wherein the first opticalfiber is not held taut along at least a portion of the length of thefirst channel and the second optical fiber is not held taut along atleast a portion of the length of the second channel.

Group H clauses:

Clause 1. An assembly comprising:

a polymeric body having walls that define a working lumen and a fiberlumen, the polymeric body having a first part in which the working lumenresides and a second part in which the fiber lumen resides, the firstpart having a first external shape and the second part having a secondexternal shape that is different from the first shape, the polymericbody having an external profile defined by a perimeter of the first andsecond parts: and

a clamp transitional between an open position and a closed position, inthe closed position the clamp applies a force on the second part of thepolymeric body to cause a deformation of the first part to cause a fullor partial closure of the working lumen, the clamp having a proximalwall and a distal wall, at least one of the proximal and distal wallshaving a through opening that has an internal profile that issubstantially similar to the external profile of the polymeric body, atleast a portion of the polymeric body residing in the through opening sothat the polymeric body is prevented from rotating in the clamp.

Clause 2. The assembly according to clause 1, further comprising anoptical fiber residing in the fiber lumen.

Clause 3. The assembly according to clause 1, wherein the working lumenis defined by a top wall having a first thickness, a bottom wall havinga second thickness and first and second side walls that each have athird thickness, the first and second side walls being located betweenthe top and bottom walls, the third thickness being less than both thefirst and second thicknesses, the dimensional characteristics of the topwall, bottom wall and first and second side walls result in a bending ofthe first and second side walls when a downward force is applied to thetop wall by the clamp, the bending allowing an inner surface of the topwall to contact an inner surface of the bottom wall to effectuate thefull or partial closure of the working lumen.

Clause 4. The assembly according to clause 1, wherein a wall segmentthat defines at least in part the fiber lumen protrudes into the workinglumen.

Clause 5. The assembly according to clause 3, wherein a wall segmentthat defines at least in part the fiber lumen protrudes into the workinglumen.

Clause 6. The assembly according to clause 5, wherein the inner surfaceof the top wall includes a recess that is configured to mate with theprotruding wall segment.

Clause 7. The assembly according to clause 2, wherein the first opticalfiber is a radially emitting fiber.

Clause 8. The assembly according to clause 2, wherein the first opticalfiber is an end emitting fiber.

Clause 9. The assembly according to clause 1, wherein the clamp includesan upper pad and a lower pad, the lower pad including a groove in whichat least a portion of the first part of the polymeric body resides.

Clause 10. The assembly according to clause 9, wherein the first partand the groove are configured to inhibit a rotating of the polymericbody in the clamp.

Clause 11. The assembly according to clause 9, wherein when clamp is inthe open position the upper pad does not press against the polymericbody and when the clamp is in the closed position the upper pad pressesdownward on the polymeric body, the clamp being continuously urged inthe open direction.

Clause 12. The assembly according to clause 11, wherein the clampincludes a latch assembly to hold the clamp in the closed position.

Clause 13. The assembly according to clause 9, wherein the clampincludes a base onto which the lower pad is attached and an arm ontowhich the upper pad is attached, the arm being joined to the base by theproximal wall.

Clause 14. The assembly according to clause 13, wherein the proximalwall includes a hinge.

Clause 15. The assembly according to clause 1, wherein the polymericbody is an infusion shaft of a central venous catheter.

Clause 16. The assembly according to clause 1, wherein each of theproximal and distal walls have a through opening that has an internalprofile that is substantially similar to the external profile of thepolymeric body, at least a portion of the polymeric body residing ineach of the through openings so that the polymeric body is preventedfrom rotating in the clamp.

Clause 17. The assembly according to clause 11, wherein the clampfurther comprises a stop to limit the amount by which the upper pad canbe pressed against the polymeric body.

Clause 18. The assembly according to clause 13, wherein a bottom of thebase includes one or more slip resistant grips.

Clause 19. The assembly according to clause 13, wherein a top of the armincludes one or more slip resistant grips.

Clause 20. The assembly according to clause 15 wherein the infusionshaft includes a proximal connector, the clamp being directly attachedto the proximal connector.

Clause 21. An assembly comprising:

a polymeric body having walls that define a first working lumen, asecond working lumen and a fiber lumen, the fiber lumen being locatedinside a septum that separates the first and second working lumens, thepolymeric body having a first part in which the first working lumen,second working lumen and fiber lumen reside, the polymeric body having asecond part that protrudes radially from the first part, the first parthaving a first external shape and the second part having a secondexternal shape that is different from the first shape, the polymericbody having an external profile defined by a perimeter of the first andsecond parts; and

a clamp that is transitional between an open position and a closedposition, in the closed position the clamp applies a force on the secondpart of the polymeric body to cause a deformation of the first part tocause a full or partial closure of at least one of the first and secondworking lumens, the clamp having a proximal wall and a distal wall, atleast one of the proximal and distal walls having a through opening thathas an internal profile that is substantially similar to the externalprofile of the polymeric body, at least a portion of the polymeric bodyresiding in the through opening so that the polymeric body is preventedfrom rotating in the clamp.

Clause 22. The assembly according to clause 21, further comprising anoptical fiber residing in the fiber lumen.

Clause 23. The assembly according to clause 21, wherein a part of theseptum that defines the fiber lumen protrudes into one or both of thefirst and second working lumens.

Clause 24. The assembly according to clause 22, wherein the firstoptical fiber is a radially emitting fiber.

Clause 25. The assembly according to clause 22, wherein the firstoptical fiber is an end emitting fiber.

Clause 26. The assembly according to clause 21, wherein the clamp iscontinuously urged in the open direction and includes a latch assemblyto hold the clamp in the closed position.

Clause 27. The assembly according to clause 21, wherein the clampincludes a base and an arm that is joined to the base by the proximalwall the through opening of the proximal wall having an internal profilethat is substantially similar to the external profile of the polymericbody.

Clause 28. The assembly according to clause 27, wherein the proximalwall includes a hinge.

Clause 29. The assembly according to clause 21, wherein the polymericbody is an infusion shaft of a central venous catheter.

Clause 30. The assembly according to clause 21, wherein each of theproximal and distal walls have a through opening that has an internalprofile that is substantially similar to the external profile of thepolymeric body, at least a portion of the polymeric body residing ineach of the through openings so that the polymeric body is preventedfrom rotating in the clamp.

What is claimed is:
 1. An assembly comprising: a first optical fiberhaving a length, a proximal end and a distal end; an infusion shafthaving a lumen in which at least a first portion of the length of thefirst optical fiber resides, the distal end of the first optical fiberbeing attached to the infusion shaft inside the lumen; a hub connectedto the infusion shaft, the hub having a first channel that houses atleast a second portion of the length of the first optical fiber, the atleast second portion of the length of the first optical fiber comprisingslack so as not to be taut along at least a portion of the length of thefirst channel.
 2. The assembly according to claim 1, wherein theinfusion shaft is a flexible structure and the hub is a rigid structure.3. The assembly according to claim 1, further comprising a main shaft,the infusion shaft and main shaft being fluidly coupled inside the hubby a conduit.
 4. The assembly according to claim 3, wherein at least aportion of the first channel resides adjacent to a side of the conduit.5. The assembly according to claim 1, wherein the first optical fiber isa radial emitting fiber that is configured to radially emit bacterialdisinfecting light to disinfect at least a portion of the infusionshaft.
 6. The assembly according to claim 1, wherein the first opticalfiber is a radial emitting fiber that is configured to radially emitbacterial disinfecting light to disinfect at least a portion of the hub.7. The assembly according to claim 1, wherein the first optical fiber isa radial emitting fiber that is configured to radially emit bacterialdisinfecting light to disinfect at least a portion of the infusion shaftand at least a portion of the hub.
 8. The assembly according to claim 1,wherein the first optical fiber is an end emitting fiber that isconfigured to end emit bacterial disinfecting light to disinfect atleast a portion of the infusion shaft.
 9. The assembly according toclaim 1, further comprising a second optical fiber that has a length andthe hub has a second channel that houses at least a portion of thelength of the second optical fiber.
 10. The assembly according to claim9, wherein the first optical fiber is a radial emitting fiber that isconfigured to radially emit bacterial disinfecting light to disinfect atleast a portion of the infusion shaft and the second optical fiber is aradially emitting fiber that is configured to radially emit bacterialdisinfecting light to disinfect at least a first portion of the hub. 11.The assembly according to claim 10, wherein the first optical fiber isconfigured to radially emit bacterial disinfecting light to disinfect atleast a second portion of the hub.
 12. The assembly according to claim9, wherein the first optical fiber is an end emitting fiber that isconfigured to end emit bacterial disinfecting light to disinfect atleast a first portion of the infusion shaft, and the second opticalfiber is a radial emitting fiber that is configured to radially emitbacterial disinfecting light to disinfect at least a second portion ofthe infusion shaft.
 13. The assembly according to claim 9, wherein aportion of the second channel overlaps a portion of the first channel.14. The assembly according to claim 9, wherein at least a portion of thelength of the first channel and at least a portion of the length of thesecond channel reside at different heights inside the hub.
 15. Theassembly according to claim 9, wherein the first optical fiber is an endemitting fiber that is configured to end emit bacterial disinfectinglight to disinfect at least a first portion of the infusion shaft, andthe second optical fiber is a radial emitting fiber that is configuredto radially emit bacterial disinfecting light to disinfect at least asecond portion of the infusion shaft and a portion of the hub.
 16. Theassembly according to claim 15, further comprising one or more opticalsurfaces through which the end emitted bacterial disinfecting lightpasses before the bacterial disinfecting light is delivered to theinfusion shaft.
 17. The assembly according to claim 9, wherein the firstoptical fiber is an end emitting fiber that is configured to end emitbacterial disinfecting light to disinfect at least a first portion ofthe infusion shaft, and the second optical fiber is also an end emittingfiber that is configured to end emit bacterial disinfecting light todisinfect at least a portion of the hub.
 18. The assembly according toclaim 17, further comprising one or more optical surfaces through whichthe end emitted bacterial disinfecting light passes before the bacterialdisinfecting light is delivered to the at least first portion of theinfusion shaft.
 19. The assembly according to claim 9, wherein the hubcomprises a raised platform that has side walls that at least partiallydefine the first and second channels, the first optical fiber beingrouted inside the hub in a clockwise direction around the raisedplatform and the second optical fiber being routed inside the hub in acounter-clockwise direction around the raised platform.
 20. The assemblyaccording to claim 9, wherein the at least portion of the length of thesecond optical fiber is not held taut along at least a portion of thelength of the second channel.
 21. The assembly according to claim 9,wherein the first optical fiber is a radial emitting fiber that isconfigured to radially emit bacterial disinfecting light to disinfect atleast a portion of the infusion shaft and the second optical fiber is aradially emitting fiber that is configured to radially emit bacterialdisinfecting light to disinfect at least a first portion of the hub. 22.The assembly according to claim 21, wherein the first optical fiber isconfigured to radially emit bacterial disinfecting light to disinfect atleast a second portion of the hub.
 23. The assembly according to claim1, wherein a portion of the infusion shaft resides inside the hub. 24.The assembly according to claim 1, wherein the infusion shaft includes aproximal connector, the lumen being located inside the proximalconnector.
 25. An assembly comprising: a first optical fiber having alength; a second optical fiber having a length an infusion shaft havinga lumen in which at least a first portion of the length of the firstoptical fiber resides; a hub connected to the infusion shaft, the hubhaving a first channel and a second channel, the first channel housingat least a second portion of the length of the first optical fiber, theat least second portion of the length of the first optical fiber is notheld taut along at least a portion of the length of the first channel,at least a portion of the length of the second optical fiber beinghoused in the second channel.
 26. The assembly according to claim 25,wherein the first optical fiber is an end emitting fiber that isconfigured to end emit bacterial disinfecting light to disinfect atleast a first portion of the infusion shaft, and the second opticalfiber is a radial emitting fiber that is configured to radially emitbacterial disinfecting light to disinfect at least a second portion ofthe infusion shaft.
 27. The assembly according to claim 25, wherein aportion of the second channel overlaps a portion of the first channel.28. The assembly according to claim 25, wherein at least a portion ofthe length of the first channel and at least a portion of the length ofthe second channel reside at different heights inside the hub.
 29. Theassembly according to claim 25, wherein the first optical fiber is anend emitting fiber that is configured to end emit bacterial disinfectinglight to disinfect at least a first portion of the infusion shaft, andthe second optical fiber is a radial emitting fiber that is configuredto radially emit bacterial disinfecting light to disinfect at least asecond portion of the infusion shaft and a portion of the hub.
 30. Theassembly according to claim 29, further comprising one or more opticalsurfaces through which the end emitted bacterial disinfecting lightpasses before the bacterial disinfecting light is delivered to theinfusion shaft.
 31. The assembly according to claim 25, wherein thefirst optical fiber is an end emitting fiber that is configured to endemit bacterial disinfecting light to disinfect at least a first portionof the infusion shaft, and the second optical fiber is also an endemitting fiber that is configured to end emit bacterial disinfectinglight to disinfect at least a portion of the hub.
 32. The assemblyaccording to claim 31, further comprising one or more optical surfacesthrough which the end emitted bacterial disinfecting light passes beforethe bacterial disinfecting light is delivered to the at least firstportion of the infusion shaft.
 33. The assembly according to claim 25,wherein the hub comprises a raised platform that has side walls that atleast partially define the first and second channels, the first opticalfiber being routed inside the hub in a clockwise direction around theraised platform and the second optical fiber being routed inside the hubin a counter-clockwise direction around the raised platform.
 34. Theassembly according to claim 25, wherein the at least portion of thelength of the second optical fiber is not held taut along at least aportion of the length of the second channel.